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210 Companies with Results for clinical development 1 - 10 of 210

Simulations Plus

42505 10th Street West Lancaster, CA 93534 Tel: +1 661 723-7723

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QST and QSP Platform Support

... help evaluate DILI risk for sponsor compounds in clinical development. Prior to DILIsym Services, Dr. Shoda worked for ... help evaluate DILI risk for sponsor compounds in clinical development. Prior to DILIsym services, Dr. Gebremichael worked in ...

Resource Center - Simulations Plus

... of Phase 2 / 3 Dosing Strategies for the Clinical Development of Doripenem Posters PK-PD Evaluation of Doripenem ( ... Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide Posters Benchmarking And Risk Adjustment Of ...

NAFLDsym® - Simulations Plus

... pharmaceutical companies, supporting clinical trial design optimization and clinical development decision making. DILIsym Services, Inc. applies the NAFLDsym ...

PBPK Modeling | Pharmacometrics | Clinical Pharmacology | PK/PD Modeling | Clinical Trial Data Analysis

Pharma + Biotech Pharma + Biotech | Clinical Development Your partner in clinical pharmacology… For Simulations Plus clients, we are able to bridge physiologically-based pharmacokinetic (PBPK) modeling with ...

PBPK Modeling Workshop | Population PK Analysis | NONMEM Workshop

... PBPK Modeling & Simulation Workshop: From Lead Optimization to Clinical Development This three-day, hands-on course provides a ... PBPK modeling and simulation software from discovery through clinical development. A combination of presentations and interactive examples, taken ...

Resource Center - Simulations Plus

... Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility Journal ... the rat: possible involvement of mrp2. Journal Articles Development of clinical dosage forms for a poorly water soluble drug ...

Resource Center - Simulations Plus

... Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility Journal ...

Simulations Plus | Modeling & Simulation Software | Consulting Solutions

... software and provide expert consulting supporting drug discovery, clinical development research, and regulatory submissions. Events Stay up-to- ...

Company Overview - Simulations Plus

... simulation software and consulting services from discovery through clinical development, with special emphasis on the QSAR-PBPK “marriage” ... PBPK and pharmacometric modeling and simulation services and clinical pharmacology support , including model-based drug development strategies, and data assembly .

PBPK Modeling | Pharmacometrics | Clinical Pharmacology | PK/PD Modeling | Clinical Trial Data Analysis

Lots of data, lots of analysis… Learn how our experts and PBPK modeling technology provides you with solutions at every phase of clinical research. ... Pharma + ...

PBPK Consulting Services | PBPK Modeling Analysis/Simulation

... all phases of drug discovery, translational research, and clinical development. If your organization does not have the time ...

Software Products - Simulations Plus

... pharmaceutical companies, supporting clinical trial design optimization and clinical development decision making. KIWI™ KIWI is a cloud-based ...

QSP Modeling of NAFLD & NASH - Simulations Plus

... pharmaceutical companies, supporting clinical trial design optimization and clinical development decision making ( Click Here for One Such Example ...

PK/PD Modeling and Analysis | Clinical Trial Simulations | Pharmaceutical and Clinical Pharmacology Consulting

... provide confidence in designing future trials. Pharmaceutical and Clinical Pharmacology Consulting We can assist your development team in all aspects of pharmacology, from study ...

Model-Driven Development Strategies - Simulations Plus

... to adopt model-based drug development. Pharmaceutical and Clinical Pharmacology Consulting We can assist your development team in all aspects of pharmacology, from the ...

Consulting Services | Model Based Drug Development

... pharmacology and pharmacometric consulting services, PK/PD model development with NONMEM, clinical trial simulations, exposure-response evaluations, dose justification strategies ...

PBPK Modeling | ADME | Drug Safety | PK/PD Modeling | Allometry

Pharma + Biotech Get to the clinic confidently… 0.02%. Of the compounds which enter preclinical development, only 0.02% become an approved drug. At this stage, the ultimate goals are to identify appropriate dose levels for the ...

Careers - Simulations Plus

... results of modeling and simulations to transform drug development. Read More Clinical Data Programmer Cognigen Corporation in Buffalo, NY Our clinical data programmers collaborate closely with internal and external project ... are developed that use advanced coding techniques while working with ...

Careers | Scientists | Pharma Research | BioChem |

Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development. Become a part of our team.

Partners and Collaborators - Simulations Plus

... Uxbridge, United Kingdom PharmaDirections: Cary, NC, USA PhinC Development: Massy, France Projections Research Inc. : Phoenixville, PA, USA Quotient Clinical: Nottingham, United Kingdom RILD: Shanghai, China Sygnature Discovery: ...

DILI-sim Initiative | Drug Induced Liver Injury Drug Development

... to liver safety signals already observed in the clinic. The goals of the Initiative are to improve patient safety, reduce the need for animal testing, and reduce the costs and time necessary to develop new drugs. The DILI-sim Initiative is led ...

Resource Center - Simulations Plus

... better tennis partner Blog Intelligent Wondering 8211 Investigative Clinical ... in Drug Development Blog Insight…Inspiration…Innovation Blog I don’t ...

DILIsym Development - Simulations Plus

... most immediately support drug development programs. We recently developed and released DILIsym v7A which includes many GUI features to help users model their compounds in the software or replicate clinical protocols. Some of these features include: In addition ...

Toxicity prediction | QSTR | Ames mutagenicity | hERG inhibition

... effect level (NOEL) of organic chemicals based on clinical trial data.” ... Development of a Quantitative Structure – Activity Relationship Model for ...

DILIsym Scientific Advisory Board - Simulations Plus

... consisting of major life science companies charged with developing the DILIsym software. As an internationally recognized expert in drug safety and a clinically trained hepatologist, Dr. Watkins has extensive research experience ...

Pharmacometric Data Assembly | CDISC Data Assembly | ADaM Standard Formats

... data providers. Simulations Plus data programmers have extensive clinical ... developing new CDISC data standards. Susanne Sardella, Associate Director ...

About - Simulations Plus

... top-quality modeling and simulation expertise that utilize clinical trial data. In September of 2016, we released ... next-generation, standalone PKPlus ™ tool for preclinical and clinical trial PK data analysis, following from the PKPlus™ ...

Biochemistry | Chemical Engineering | Biomedical Engineering | Pharma

... be presented from different angles by presenting non-clinical information from in vitro studies, clinical studies as well as PBPK simulations linking non- ...

Leadership - Simulations Plus

... Ted has extensive experience in modeling and simulation, clinical pharmacology, and outcomes research. Ted has built Cognigen ... industry leader in the high-quality analysis of clinical trial data, serving customers ranging from top-5 ...

DILIsym® - Drug-induced liver injury (DILI) modeling software

... induced liver injury risk in upcoming experimental or clinical study designs, as well as mechanistic rationale for ... immune responses. To facilitate comparison with high-level clinical and preclinical readouts, DILIsym includes the release of ...

FAQs - Simulations Plus

... validate the model include scientific literature, novel experiments, clinical trials and reports, expert opinions, and basic biological ... consortium members approve the particular aspects of model development through voting, ultimately shaping DILIsym to focus on ...

Resource Center - Simulations Plus

... PKPlus™ – The next-generation software for preclinical and clinical trial data analysis Webinars Using GastroPlus™ Modeling to Eliminate Bridging Clinical Studies for Late Webinars ADMET Predictor – Your user ...

Resource Center - Simulations Plus

... Cavity Model and Its Application for Projection of Clinical Pharmacokinetics of Intermezzo® Sublingual Tablets Posters Novel Skin ... midazolam pharmacokinetics after intranasal administration in children Posters Development of a mechanistic in vitro – in vivo correlation ...

Lead discovery process | Ligand based design | Drug-like/lead-like/fragment-like filters | HTS analysis | QSAR | ADMET Properties | Lead Candidate Selection

... process to maximize your chances of success in clinical trials. ... desired potency, selectivity, and ADMET properties for pre-clinical evaluation. The figure below describes a typical lead ...

Generic Drugs | Bioequivalence Study | IVIVC FDA | Formulation Development | Dissolution Method

... running all sorts of in vitro tests and clinical trials to prepare for the 505(b)(2) ...

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... simulation software and consulting services from discovery through clinical development, with special emphasis on the QSAR-PBPK “marriage” ... PBPK and pharmacometric modeling and simulation services and clinical pharmacology support , including model-based drug development strategies ,

PPD® Laboratories

929 North Front Street Wilmington, NC 28401-3331 Tel: 919-380-2000

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Clinical Development Services

PARTICIPATE IN A TRIAL Menu Clinical Development Services Clinical Development Comprehensive product development services to address multiple drug development challenges and the growing complexities of conducting multinational clinical ...

Preclarus® - PPD

... trial innovation Preclarus As a global leader in clinical development, PPD is advancing clinical research through the innovative ... data Learn More Continuously Innovating Enabling advances in clinical development Learn More Connect With Us We want to ...

Biosimilar Biological Development Services – PPD® Consulting

... a full range of consulting, regulatory, laboratory and clinical development services to support biosimilar product development. We are ... full range of GMP and bioanalytical lab and clinical development services, which support a seamless approach to biosimilar ...

Early Clinical Development & Post-Approval Planning | PPD

... ever to integrate post-approval strategies with your clinical development plans. Activities traditionally focused on the post-approval ... be defined throughout the product life cycle: Early Clinical Development - Phase II Phase III Approval/Product Launch Post- ...

Preclarus® Resources

... analysis solution. Preclarus As a global leader in clinical development, PPD brings you real-time access to study ... analysis solution. Preclarus As a global leader in clinical development, PPD brings you real-time access to study ...

Preclarus® Innovations - PPD

... to foster new and disruptive ideas across the clinical development process. We are committed to ongoing investment and ... of Preclarus—an industry-leading platform to revolutionize clinical drug development. Harmonized Lab Data The central lab database and ...

Patient Safety in Clinical Trials

... Menu Patient Safety in Clinical Trials PPD’s clinical development group gives clients access to a dedicated pharmacovigilance ... of safety services for your drug safety and development programs. At the same ... trial pharmacovigilance practices. Full Product Lifecycle Approach PPD ...

CRO providing drug discovery, development and lifecycle management services | PPD

... Phase I clinical trial services and nonclinical consulting. Clinical Development Find out how PPD’s clinical development services can help advance drug research and development ...

Pharmacovigilance Services

... effective governance and continuous process improvement from early clinical development to marketed product support. Through efficiencies, maintaining quality ...

About PPD; Services, Therapeutic Expertise and Strategic Partnerships

... life-changing therapies to improve health. Early Development Clinical Development PPD Laboratories Post-Approval Consulting Company Accolades Our ... for company activities. CRO Overview Learn about CROs, clinical trials and an ... development process. Investor Relations PPD’s commitment to financial ...

Qualified Person (QP) Release Services

PARTICIPATE IN A TRIAL Menu Qualified Person (QP) Release In Europe, PPD has qualified persons (QPs) who are experienced and trained in the European Union ( ...

Clinical Trial Monitoring Services

PARTICIPATE IN A TRIAL Menu Clinical Trial Monitoring Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review ...

Global Clinical Supply Management | PPD

PARTICIPATE IN A TRIAL Menu Global Clinical Supply Services We help clients proactively solve potential product packaging, labeling and release process ...

Adaptive & Intelligent Monitoring - PPD

PARTICIPATE IN A TRIAL Menu Adaptive and Intelligent Monitoring Better, faster information collection and analysis are the foundations of enhanced clinical ...

Clinical Data Interchange Standards Consortium (CDISC) Experience | PPD

... using the Standard Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC). This guidance is ...

Therapeutic Area Consulting Services | PPD® Consulting

... practice and state-of-the-art approaches to clinical development planning. Our expertise includes: Overcome Challenges and Increase ... adept at assisting clients in anticipating and overcoming clinical and ... product development, saving time and enabling the achievement of timely, ...

Site and Patient Services

... Through ongoing partnerships and innovative pilots, PPD is developing new clinical trial models that encourage study participation and reduce ...

PPD-SNBL: Clinical Trial Capabilities in Japan

... labs and biomarkers. Our laboratory services accelerate pharmaceutical development for small molecules, biologics and vaccines, allowing our clients to make faster decisions about their compounds.

Clinical Biostatistics Services

... Comprehensive Experience, Tailored Biostatistics Services PPD's extensive ... plan, the statistical analysis implementation provides clients with ...

Adaptive Clinical Trial Design - PPD® Consulting

... Trial Design Reducing Costs and Improving Efficiency in Clinical Development Adaptive trial designs offer significant benefits for biopharmaceutical ... is a statistical consulting group specializing in adaptive clinical trial design in ... PPD formally collaborates with Berry Consultants to complement ...

Clinical Trial Quality Assurance Services | PPD

... assurance audits we conduct are: Contact Us Good Clinical Practice Jay Dixon, senior vice president, global quality and compliance, discusses the evolving drug development paradigm from a CRO perspective. Read More Connect ...

Clinical Data Management Services

PARTICIPATE IN A TRIAL Menu Quality Data, Leading Clinical Data Management Technologies The integrity of clinical data is of paramount importance to a ...

Nonclinical Development and Chemistry Manufacturing and Controls Services | PPD

... nonclinical program that is optimized to support your clinical development and regulatory plans. Our expert pharmacology/toxicology and ... spectrum, including: Through close collaboration with PPD’s clinical pharmacology ... from product discovery through post-approval lifecycle management. ...

PPDI

... devoted to finding the right Phase I-IV clinical development solutions for biotech and small to midsize pharma ... medical officer at CeNeRx BioPharma, a venture-backed clinical-stage biotech, where he ... Centre at GlaxoSmithKline with global responsibility for Phase ...

Global Project Management Services

... project manager: Contact Us Preclarus® PPD is advancing clinical research ... Policy © 2018 Pharmaceutical Product Development, LLC. All rights reserved.

PPD® Laboratories Central Lab | PPD

... in real time. For studies utilizing PPD for clinical development and central lab services, data from the Preclarus central lab database can be automatically integrated with patient/medical data from PPD’s clinical trial management system. Visibility to integrated clinical and ...

PPD Laboratories Functional Service Partnerships (FSP)

... regulatory compliance. Learn more about PPD FSP for clinical development services . Explore our experience: Connect With Us We ...

Regulatory Affairs Brochure - PPD

PARTICIPATE IN A TRIAL Menu Regulatory Affairs Brochure Our end-to-end regulatory solutions ensure compliance throughout the product life cycle while ...

Contact PPD

... below to request more information or provide feedback. Clinical Development Services PPD Laboratories Services Early Development Services Peri- ...

Pharmacovigilance Expertise

PARTICIPATE IN A TRIAL Menu Pharmacovigilance Expertise PPD’s motivated pharmacovigilance staff offers stability that comes from years of experience, ...

Interactive Response Technology (IRT) Services | PPD

PARTICIPATE IN A TRIAL Menu Interactive Response Technology (IRT) Services Our dedicated team of experienced professionals delivers the following suite ...

Preclarus® Dynamic Visualizations - PPD

PARTICIPATE IN A TRIAL Menu Preclarus : Dynamic Visualizations Consolidated Data, Actionable Intelligence Preclarus dashboards deliver unprecedented reporting ...

Innovation at PPD

PARTICIPATE IN A TRIAL Menu Innovation at PPD What is Innovation? Innovation is an essential part of PPD's success and strategy. PPD continually seeks ...

Global Regulatory Affairs Services

PARTICIPATE IN A TRIAL Menu Global Regulatory Affairs Services PPD provides effective global regulatory affairs services for all stages of pharmaceutical, ...

Preclarus® Login

PARTICIPATE IN A TRIAL Menu Preclarus Login Contact Us Connect With Us We want to hear from you Investigators Needed Register in PPD's Database Stay Connected ...

Preclarus®: Real-time Data - PPD

PARTICIPATE IN A TRIAL Menu Preclarus : Real-time Data Delivering real-time data is at the heart of a research revolution that is based on knowing more ...

PPD’s fight against tuberculosis: Clinical trials with experienced teams | Blog

... having spent 25 years focused on public health clinical development. “I came to PPD having successfully developed and ...

Using Precision Medicine to Improve Patient Care - PPD White Paper

PARTICIPATE IN A TRIAL Menu Using Precision Medicine to Improve Patient Care This paper, part one in a series, discusses how precision medicine can be ...

Flexible Systems and Technologies

PARTICIPATE IN A TRIAL Menu Flexible Systems and Technologies PPD has extensive experience efficiently and successfully managing and controlling project ...

Marketed Products

PARTICIPATE IN A TRIAL Menu Marketed Products PPD’s global pharmacovigilance group gives clients access to scalable, flexible technologies and resourcing ...

Early Development Services - Clinical Research & Trials | PPD

... chemistry, manufacturing and controls (CMC) consulting services. Early Development Clinical Research Services PPD is experienced in conducting complex, ...

Phase I Services - Clinical Research & Trials | PPD

PARTICIPATE IN A TRIAL Menu Early Development Clinical Research Services Early Phase. Early Insights. Early Decisions. Specialized experience in early development. PPD is experienced in conducting complex, procedurally intensive early ...

Pediatrics Expertise | PPD® Consulting

... mitigation strategies and to manage the execution of clinical studies and associated development activities in this unique setting. End-to-End ... our expertise includes: Significant Experience in Pediatric Drug ... attendant upon clinical trials in children, enabling us to identify sites ...

Regulatory Affairs Services | PPD® Consulting

... in preclinical ; chemistry, manufacturing and controls (CMC) ; and clinical and commercial development to build strategies that meet the demands of ...

Medical Device and Diagnostic Expertise | PPD® Consulting

... provide innovative, results-focused support for our clients' clinical and regulatory needs. Comprehensive Development Services PPD’s cross-functional medical device and ...

Post-Approval Services - Post-Approval Studies & Late Stage Research | PPD

... and value of biopharmaceutical and biotechnology products. Our clinical experience in product development ensures collaboration and integration from pre-approval to ...

Phase I Research Clinic Integrated Services | PPD

... PPD's early development services support your specialized clinical research needs. PPD's specialized early development services team is solely dedicated to early phase ...

Phase I Research Clinic Capabilities and Services | PPD

... and clinical pharmacology. The experienced team leading the clinic brings a depth of specialized expertise in early development studies. For example, the team is skilled in ...

Product Development Consulting Services | PPD® Consulting

... adept at assisting clients in anticipating and overcoming clinical and regulatory challenges in product development. Regulatory Affairs PPD offers a complete spectrum of ...

Product Development Consulting Services | PPD

... Pediatrics We understand the challenges associated with conducting clinical research in children. Cardiovascular Outcomes PPD offers strategic development expertise, global access and operational infrastructure for your ...

Participate in a Clinical Trial with PPD

... Unit Las Vegas Clinical Research Unit Investigators As clinical trial investigators, physicians play an integral role in the development of life-changing medicines. Help Yourself While Helping ...

Phase I Research Clinic Capabilities and Services | PPD

... required diagnostic tests. Special Volunteer Populations PPD's clinical research ... services team supports site identification, selection and management ...

PPD and Quotient Sciences

... end support for all stages of pediatric drug development — from chemistry and manufacturing through all clinical trial phases and commercial manufacturing. Through our partnership ...

Pharmacology & Toxicology Consulting, Pharm/Tox Consulting Services | PPD

... department work closely with pharmacokineticists in PPD's clinical pharmacology group to design and implement comprehensive nonclinical plans to enable successful product development from preclinical through post-approval lifecycle management. Our ...

Patient Registries & Observational Studies | PPD

... We assign project managers who have experience in clinical and late stage research. Contact Us Pregnancy Registry Strategies in Late Phase Development Explore strategies for pregnancy registries in late stage ...

Bioanalytical Lab Capabilities - PPD Laboratories

... compliant assays we have the technology platforms, the clinical expertise and the collaborative and flexible mindset needed to develop customized solutions for our clients. We have a ...

Vaccine Sciences Laboratory Services | PPD Laboratories

... to successfully complete vaccines studies. PPD provides integrated clinical and laboratory vaccine expertise and global resources to advance our clients’ vaccine programs. Our robust end-to-end development solutions include: PPD named Best Contract Research Organization ...

Chemistry, Manufacturing and Controls (CMC) Services | PPD® Consulting

... in virtual and start-up biotech operations. Product Development and Regulatory Strategies CMC Regulatory Services Active Pharmaceutical Ingredients (API) and Clinical Trial Material Sourcing and Management Customized Solutions for ...

Global Chemistry, Manufacturing & Controls (CMC) Regulatory Services | PPD

... expertise in all areas of CMC development: Product Development and Regulatory Strategies CMC Regulatory Services Active Pharmaceutical Ingredient (API) and Clinical Trial Material Sourcing and Program Management Capabilities Customized ...

Real-world Outcomes | PPD

... allow our clients to: The science includes objective clinical outcomes as well ... development process. PPD’s epidemiology and health outcomes experts ...

Functional Service Partnerships | PPD

... time cost and cost time curve of drug development. Our dedicated business unit focuses on our full range of FSP services, including clinical monitoring, regulatory strategy and document preparation, data management, ...

Late Stage Clinical Research Management Services | PPD

PARTICIPATE IN A TRIAL Menu Late Stage Research PPD’s late stage experts work closely with you to develop creative, flexible solutions to help you realize ...

Cardiovascular Outcomes Clinical Studies | PPD® Consulting

... data on incidence and event rates help you develop optimized protocol designs and determine the best patient populations and centers, as well as the necessary clinical trial patient recruitment strategies to ensure you secure ...

Bioanalytical Laboratory Services | PPD

... compliance with good laboratory practice (GLP) and good clinical laboratory ... test methods are being developed on a continual basis in response to our ...

Preclarus® Investigator Site Portal - PPD Central Lab

... site portal, PPD Clicks is available for the clinical team and provides: ... Policy © 2018 Pharmaceutical Product Development, LLC. All rights reserved.

Clinical Trial Project Management Services and Support for Post-Approval Trials | PPD

... defined by the client. Leadership, Communication, Results A clinical trial ... Policy © 2018 Pharmaceutical Product Development, LLC. All rights reserved.

Post-Approval Clinical Trial Monitoring Services | PPD

PARTICIPATE IN A TRIAL Menu Clinical Trial Monitoring Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of clinical data and effective ...

Central Lab Capabilities - PPD Laboratories

... cell-based assays and flow cytometry under good clinical laboratory practice (GCLP) and/or clinical laboratory improvement amendment (CLIA) regulations. Our central lab ...

Biomarker Lab Capabilities - PPD

... GCLP compliance. The lab also provides training to clinical sites on proper sample processing for complex procedures, ... the needs of the program or phase of development of the biomarker. Our biomarker experts are in ...

Clinical Laboratory Services Technology & Research | PPD Laboratories

... you get the best data possible for each development phase. At PPD Laboratories there are no cookie- ... scientists have completed more than 17,000 pharmaceutical development projects and worked with more than 8,000 ...

Phase IV Monitored Clinical Trial Services and Support | PPD

... that support product success in a real-world clinical practice. With our extensive Phase IIIb-IV experience, ... Slavery Transparency Statement Privacy Policy © 2018 Pharmaceutical Product Development, LLC. All rights reserved.

Preclarus® Central Lab Database - PPD Central Lab

... study data from PPD Laboratories’ central lab, combined clinical and laboratory data can be accessed by project ... and clients transparent, real-time access to all clinical trial operations and patient data which can be ...

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PARTICIPATE IN A TRIAL Menu Clinical Development Services in Japan PPD-SNBL, one of the largest clinical development service providers in Japan, was formed when PPD entered into ...

PRA Health Sciences

4130 ParkLake Avenue Suite 400 Raleigh, NC 27612 Tel: 856-533-5016

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... broad spectrum of solutions, ranging from full-service clinical development to our pioneering Embedded model. With 11,000+ ... Over the years, we have contributed to the development of numerous drugs now ... provide the commitment and expertise needed for today’s complex studies.

Cardinal Health Regulatory Sciences

7400 W. 110th Street, Ste. 300 Overland Park, KS 66210 Tel: 913-451-3955

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Since 1976, Cardinal Health Regulatory Sciences has been partnering with pharmaceutical, biotechnology and medical device ...

Quay Pharma

Quay House 28 Parkway Deeside Industrial Park Slintshire Tel: 44-1244-837000

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About Us - Quay Pharma

... successfully licensed or in the latter stages of clinical development. We have also helped with the successful development ... successfully licensed or in the latter stages of clinical development. We have also helped with the successful development ...

Pharmaceutical Services - Quay Pharma

... bring drug products through the various stages of clinical development quickly and cost-effectively. Quay Pharma have the ... small-scale commercial manufacturing. Pharmaceutical Services Preformulation Formulation ... Phase II & III Clinical Manufacturing Commercial Manufacture & ...

What We Do - Quay Pharma

... bring drug products through the various stages of clinical development; from pre-formulation work to formulation, dosage form ...

Live Biotherapeutics Drug Delivery - Quay Pharma

... provide a formulation with the best chance of clinical outcome. Our formulation development and clinical services include: Live Biotherapeutic Oral Dosage ...

The Team - Quay Pharma

... Their expertise covers chemistry, analytical chemistry, preclinical and clinical formulation development, pharmaceutical development and quality assurance. Professor Mike Rubinstein ...

Orphan Drugs - Quay Pharma

... to deliver an Orphan Drug molecule from pre-clinical and formulation development all the way to small scale commercialisation. As ... with our clients. More Pharmaceutical Services Preformulation Formulation Development ... Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Phase I Clinical Manufacturing - Quay Pharma

... Pharmaceutical Services We are extensively involved in the development of early clinical formulations and clinical manufacturing of First in Man ... please contact us More Pharmaceutical Services Preformulation Formulation Development ... Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Formulation Development - Quay Pharma

... best formulation development and the best chance of clinical success. A large suite of formulation development services are offered at Quay Pharma, which include: ...

Analytical Services - Quay Pharma

... factor of our success in early stage formulation development, stability studies and clinical trial manufacture. Analytical & Quality Control Services Include: Our ...

Commercial Manufacture & Packaging - Quay Pharma

... Quay Pharma’s service offering now allows for development from late pre-clinical through to commercial manufacture. The application ran in ... services. Services Include: More Pharmaceutical Services Preformulation Formulation ... Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Phase II & III Clinical Manufacturing - Quay Pharma

... production capabilities include More Pharmaceutical Services Preformulation Formulation Development Analytical Services Phase I Clinical Manufacturing Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Preformulation and Preclinical Studies - Quay Pharma

... strategy designed to help your drug progress into clinical use. Our Preformulation Capabilities Include: More Pharmaceutical Services Preformulation Formulation Development Analytical Services Phase I Clinical Manufacturing Phase II & ...

Capsules - Quay Pharma

... Phase I (First in Man) studies, allowing a clinical product to be produced quickly with minimal development and using very little API. We also have ...

Clinical Trial Supply - Quay Pharma

... basis if required. More Pharmaceutical Services Preformulation Formulation Development Analytical Services Phase I Clinical Manufacturing Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Specials Manufacturing Services - Quay Pharma

... Manufacturing Capabilities Include: More Pharmaceutical Services Preformulation Formulation Development Analytical Services Phase I Clinical Manufacturing Phase II & III Clinical Manufacturing Commercial Manufacture & ...

Quay Pharma

... targeted... Read more Live Biotherapeutics Experienced in formulation development, currently one of the few companies licensed for the clinical manufacture of live... Read More Phase 1 Clinical ...

Conventional Dosage Forms - Quay Pharma

... of innovative technologies to overcome the barriers to clinical progress. We ... our Business Development team will be happy to help. Alternatively, fill ...

Pharmaceutical Technology - Quay Pharma

... to give it the best possible chances of clinical and commercial success. To do this, we have an extensive portfolio of pharmaceutical technologies that allow us to develop formulations that present particular challenges. Complementing our more ...

Solubility & Bioavailability Enhancement - Quay Pharma

... techniques are required to to turn them into clinically effective products Class 4 (Low Solubility) Class 4 contains substances that neither dissolve nor penetrate physiological barriers to enter the body. They are not usually developed further, although they may have some application when ...

How We Work - Quay Pharma

... of drug product, QP release to client or clinic and ICH compliant ... our Business Development team will be happy to help. Alternatively, fill ...

Facilities - Quay Pharma

... and, because we supply a large volume of clinical trial products to North ... our Business Development team will be happy to help. Alternatively, fill ...

Lipophilic Systems - Quay Pharma

... that your drug may be encountering, and then developing suitable formulations using ... product for clinical studies that will give your drug product the ...

Modified Release Technologies - Quay Pharma

... life cycle in the market. Others arise from clinical considerations like the importance of taking a drug ... life cycle in the market. Others arise from clinical considerations like the importance of taking a drug ...

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... bring drug products through the various stages of clinical development quickly and cost effectively, and we have the ... facilities. By drawing on our considerable experience of developing new dosage ... specials manufacturing and even small-scale commercial manufacturing.

Ajinomoto Althea, Inc.

11040 Roselle Street San Diego, CA 92121 Tel: 858-882-0123

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Stability and Release Tests - Althea

... analytical team is in direct communication with your clinical development team consistently sharing data, coordinating schedules, and planning ...

Drug Formulation, Clinical Drug Development - Althea

... challenges with stability, efficacy, potency, or safety during clinical and commercial phases. Althea has extensive experience in implementing clients’ developed formulation methods into GMP compliant processes to ensure ...

Analytical Services, Complex Formulation Manufacturing - Althea

... appropriate Analytical Services result in timely and efficient clinical drug development. Althea’s analytical scientists are a highly seasoned ...

Crystalomics, Contract Manufacturing Organization – Althea

... a timely and cost-effective solution for your clinical drug development needs. An article from – Biological Characterization Using Protein ... both pharmaceutical developers and, more importantly, patients. ... clinical stage and commercial manufacturing Self-injection that doesn’ ...

J. David Enloe Jr, President and Chief Executive Officer, Althea

... 20 years of executive management experience in biotechnology, clinical drug development and GMP Manufacturing. Mr. Enloe is very active ...

Ajinomoto Althea, Inc. Launches Process and Analytical Development Services for Antibody Drug Conjugates (ADCs) Therapeutics - Althea

... low Occupation Exposure Limit (OEL) payloads for pre-clinical studies. The Analytical Development labs will support process development services such as ...

Company Profile & History - Althea

... fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical ...

Ajinomoto Althea Inc. Now Offering A Novel Protein Production Platform: Corynex® - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling ...

Fill Finish, Aseptic Filling - Althea

... to advance your projects through all stages of clinical and commercial development. Our aseptic fill finish projects for clinical batches can be as small as 100 units ...

Pfenex Inc. Awards Althea Technologies a Contract for cGMP Manufacturing of Circumsporozoite Protein from Plasmodium falciparum, a Key Malaria Antigen - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Biologics candidate manufactured using Ajinomoto Co., Inc.’s CORYNEX® Protein Expression System enters clinical trials for the first time - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Althea Technologies & Profectus Biosciences Sign Manufacturing Agreement for Plasmid DNA Production - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Ajinomoto Althea, Inc. Expands Its Capacity of Fill Finish Manufacturing with Addition of Second Shift - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Ajinomoto Althea, Inc. Appoints Dr. Lori McDonald as Vice President of Compliance - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Althea Technologies Announces Expanded Roles for Key Executives - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Ajinomoto Althea, Inc. Expands Manufacturing Capabilities to ADC Fill Finish and Bioconjugation - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Althea’s New Drug Formulation Technology Gains Attention from Two More Top Pharmaceutical Companies - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Ajinomoto Althea, Inc. Receives European GMP Certification for Commercial Aseptic Filling and Testing - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea, Inc. offers cGMP drug product ...

Ajinomoto Althea, Inc. Awarded CA Tax Credit - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea, Inc. offers cGMP drug product ...

Ajinomoto Althea Inc. Appoints J. David Enloe as President and Chief Executive Officer - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling ...

Ajinomoto Althea, Inc. Selected as a Finalist in 26th Annual CONNECT Most Innovative New Product Awards - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling ...

Ajinomoto Co., Inc. Completes Acquisition of Althea Technologies, Inc - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Ajinomoto Althea, Inc. Announces Issuance of New US Patent for Manufacturing of Crystal Monoclonal Antibodies - Althea

... manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

Antibody Drug Conjugate Manufacturing - Althea

... and will include capability for process development, analytical development, formulation, clinical and commercial manufacturing for bio-conjugation and fill ...

ADC Manufacturing Services and Capabilities - Althea

... scale UF/DF development Chromatography methods development Formulation development Material generation for pre-clinical studies including analytical characterization Analytical Capabilities MALS/IR ...

Drug Product Manufacturing, Drug Formulation Services - Althea

... in handling complex sterile manufacturing challenges. Speed to Clinic and Market With speed and flexibility, we are responsive to the shifting demands of early development. We will work collaboratively with you to ensure ...

Process Development, cGMP Production - Althea

... Current Good Manufacturing Practices (cGMP) production, the Process Development team designs manufacturing processes to support Phase I – III clinical trials and assesses how robust a process is, ...

cGMP Manufacturing, Biologics Manufacturing – Althea

... drug substance. As your program advances in the clinic, Althea provides the ... development and cGMP manufacturing, the Althea manufacturing team works ...

Press Archive - Althea

... Co., Inc.’s CORYNEX® Protein Expression System enters clinical trials ... Development Services for Antibody Drug Conjugates (ADCs) Therapeutics Read ...

Drug Substance Manufacturing, cGMP Microbial Fermentation

... gene therapy products. Althea has demonstrated experience in developing and ... and clinical supply. For additional information about Althea’s drug ...

Regulatory Support - Althea

... is ready to help with your regulatory submissions, clinical filings and commercial launch. cGMP validated Part 11 ... operational metrics with the senior management team and developing actions to drive optimization of processes. We are ...

The Power To Make - Althea

... who shares your unwavering tenacity and dedication from clinical studies through commercial success. That’s The Power ... Civil War Commander Chris Olson Director of Business Development Favorite: Past Time: Surfing Movie: Caddyshack Show: 60 ...

Ajinomoto Althea, Inc. Announces New Aseptic Fill Finish Line - Althea

... s ability to meet the needs of its clinical and commercial clients. Stacy Sutton, Head of Engineering, ...

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... fully integrated, contract development and manufacturing organization providing clinical and commercial product development services. Althea offers cGMP drug product filling in ...

HTD Biosystems

1061 Serpentine Lane Suite E Pleasanton, CA 94566 Tel: 510-367-0528

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Formulation Development

... biotech drug substance to transit from discovery to clinic. We provide services for product and process development of biopharmaceuticals using a rational formulation design strategy ...

HTD Biosystems Services- Pleasanton, CA

... HTD Biosystems are currently at different stages of clinical trials. HTD has been involved in development of traditional aluminum salt based vaccines (such as ...

HTD Biosystems About us- Pleasanton, CA

... example of a product that was formulated and developed at HTD Biosystems ... is now in Phase II clinical trials. Contact us today to discuss your needs. ...

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... biological drug candidates from the bench to the clinic. Our capabilities include: • Formulation & Lyophilization Development • GLP Manufacturing of Tox lots • Biophysical Characterization Our ...

CoreRx, Inc.

14205 Myerlake Circle Suite 8 Tampa, FL 33760 Tel: 727-259-6950

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About CoreRx | Contract Development & Manufacturing Organization

... development manufacturing organization (CDMO) with a focus on clinical phase drug product development, offering state of the art facilities to support ...

Pharmaceutical Contract Packaging Services | Pharmaceutical Formulation & Development of Tablets

... phase of development. Analytical and Stability CoreRx formulation development and clinical manufacturing efforts are fully supported by our in-house analytical laboratories. Equipped with state-of-the-art instruments, CoreRx ... drug product performance testing, stability and more. Manufacturing ...

Analytical and Stability | CoreRx® | CDMO | Clearwater, Florida

Analytical and Stability Drug product development and clinical manufacturing efforts at CoreRx are fully supported by our cGMP compliant in-house analytical laboratories. Equipped with state of the art ...

Case Studies | CoreRx® | CDMO | Clearwater, Florida

... design” matrix to over-lay the phase I clinical data. The product is currently in Phase III development. Unique Product Reformulation Reformulation to Achieve Acceptable Stability ...

CoreRx Completes Private Placement; Appoints New Members to its Board of Directors | CoreRx®

... early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. From first-in-man drug development to full cGMP manufacturing support , CoreRx combines 200+ ...

Bioavailability enhancements, a long-standing problem for drug developers | CoreRx®

... pharmacokinetic and bioavailability characteristics accounted for 40% of clinical-stage pipeline failures. Over the next 10 years, drug developers got much better at spotting drugs with these ...

leon & Bionpharma co-share product Development at CoreRx | CoreRx®

... has also initiated work on its own internal development projects, concentrating on nanotechnology-based reformulations that offer enhanced clinical and safety benefits. About Bionpharma Inc Bionpharma Inc ( ...

Core Management Team | CoreRx® | CDMO | Clearwater, Florida

... has provided him exposure acoss the entire drug development paradigm, including experience in discovery, preclinical, CMC and clinical trial activities. Mark holds both a MBA in ...

CoreRx partners with leon-nanodrugs | CoreRx®

... has also initiated work on its own internal development projects, concentrating on nanotechnology-based reformulations that offer enhanced clinical and safety benefits. Todd Daviau, CEO of CoreRx ...

CoreRx and Aimmune Therapeutics Joint Expansion to Create Pharmaceutical Jobs and Increase the Base of Scientific Capabilities in the Tampa Bay Area | CoreRx®

... expansion of Myerlake-3. CoreRx is a contract development and manufacturing organization (CDMO) servicing the pharmaceutical and biotechnology industries, and Aimmune is a clinical-stage biopharmaceutical company advancing a therapeutic approach for ...

Tools and Techniques for Bioavailability Enhancements | CoreRx®

... Munich. Dr. Beier holds a Ph.D. in Clinical Pharmacology from the University ... developer of the high throughput permeability analyzer, and subsequently ...

CoreRx adds Increasing Capacity | CoreRx®

... plans for continued expansion of its drug product development and manufacturing ... clinical studies. With the new expansion, CoreRx’s clients ...

Private equity infusion paves way for expansion, jobs at CoreRx | CoreRx®

... manufacturing, a 2,000-square-foot multi-use clinical suite, and an 8,000-square-foot environmentally ... 727.683.9530 Impopharma: Analysis Pulmonary and Nasal development CoreRx and Aimmune Therapeutics Joint Expansion to Create ...

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... support your supply chain needs throughout the entire clinical trial process. Our integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi- ...

Corden Pharma International

2075 55th St Boulder, CO 80301-2803 Tel: +1 781 305-3332

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CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug ...

PCI Pharma Services

3001 Red Lion Road Philadelphia, PA 61109 Tel: 215-613-3600

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... technology and continued investment enables us to address development needs throughout the product life cycle — from Phase I clinical trials through commercialization and ongoing supply. Our clients ...

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