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165 Companies with Results for clinical development 1 - 10 of 165

PRA Health Sciences

4130 Research Park Blvd 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.

Simulations Plus

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

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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 ...

Resource Center - Simulations Plus

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

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 ...

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 Consulting Services | PBPK Modeling Analysis/Simulation

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

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 ...

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

Pharma + Biotech Pharma + Biotech | Preclinical Development 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 ...

Careers - Simulations Plus

... results of modeling and simulations to transform drug development. Read More Clinical Data Programmer East Coast Our clinical data programmers collaborate closely with internal and external project teams at Cognigen ... are developed that use advanced coding techniques while working with ...

Simulations Plus | Modeling & Simulation Software | Consulting Solutions

... hundreds of organizations, spanning all aspects of drug development from early discovery chemistry through clinical trials and on to generics, depend on us ...

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: ...

Resource Center - Simulations Plus

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

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 ...

Resource Center - Simulations Plus

... Is a New Target for Anti-AIDS Drug Development: Identification of DCIR/HIV-1 ... Predict Clinical Drug–Drug Interactions Webinars Analysis of the Tox21 ...

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™ ...

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 ...

PBPK Modeling Workshop | Population PK Analysis | NONMEM Workshop

... 2017 Cambridge, Massachusetts The Advanced GastroPlus™ DMPK and Clinical Pharmacology Workshop This 2-day hands-on course ... as it applies to problems facing DMPK and Clinical PK/PD scientists dealing with complex effects on ...

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 | Diverse screening collection | Drug-like/lead-like/fragment-like filters | HTS analysis | QSAR | Virtual libraries | Similarity searching | 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 Share this Clinical Development Services Clinical Development Comprehensive product development services to address multiple drug development challenges and the growing complexities of conducting multinational clinical programs. Our ...

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 ...

Urinary Incontinence White Paper - PPD

... incontinence is a compelling and promising area in clinical development that can address many unmet needs in women ... successfully develop new treatments. PPD has the medical, clinical development and operational expertise to understand intricacies of this ...

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

... this 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 ...

Major clinical trial reforms underway in China's regulatory environment | Blog

... new drug innovators. They can have a full clinical development program inside China with a much shorter regulatory ... China and foreign new drug companies to have clinical development in China and to have drug registration and ...

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 that 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 Share this Qualified Person (QP) Release In Europe, PPD has qualified persons (QPs) who are experienced and trained in the European ...

Clinical Trial Monitoring Services

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

Global Clinical Supply Management | PPD

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

Adaptive & Intelligent Monitoring - PPD

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

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, ...

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 ...

Site Intelligence and Activation Services - Site Activation - PPD

... will ensure heavy use of data analytics and clinical experts to inform the process for protocol development, trial planning and optimization, strategic selection of sites ...

Clinical Data Management Services

... project includes: Comprehensive Clinical Trial Data Management Our clinical ... Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved.

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.

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. ...

Site Intelligence and Activation Services - Patient Recruitment - PPD

... integrating key services from the outset of protocol development and effectively leveraging data-driven planning and decisions through all aspects of the clinical trial process. Acurian’s best-in-class analytics ...

Site Intelligence and Activation Strategic Feasibility - PPD

... is tailored to the needs of the planned clinical trial or program. Contact Us ... Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved.

Global Project Management Services

... project manager: Contact Us Preclarus® PPD is advancing clinical research ... Policy © 2017 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 ...

Site Intelligence and Activation Feasibility Services - Trial Optimization - PPD

PARTICIPATE IN A TRIAL Menu Share this Trial Optimization Through trial optimization services, PPD offers clients time-, quality-, and cost-effective ...

Pharmacovigilance Expertise

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

Preclarus® Dynamic Visualizations - PPD

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

Innovation at PPD

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

Global Regulatory Affairs Services

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

Preclarus® Login

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

Preclarus®: Real-time Data - PPD

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

Site Intelligence and Activation (SIA) - PPD

PARTICIPATE IN A TRIAL Menu Share this Site Intelligence and Activation As drug development moves through a period of significant innovation and complexity, ...

Site Intelligence and Activation Feasibility Services - Protocol Optimization - PPD

PARTICIPATE IN A TRIAL Menu Share this Protocol Optimization PPD’s protocol optimization group works with clients to design an effective protocol to achieve ...

Flexible Systems and Technologies

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

Marketed Products

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

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 Share this Early Development Clinical Research Services Early Phase. Early Insights. Early Decisions. ... with PPD’s expertise and experience conducting complex clinical trials, will ... clients gain efficiencies and accelerate timelines through integrated ...

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 ...

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 ...

Pediatric research: Overcoming challenges and building community | Blog

... to conducting clinical research in this population, but clinical studies are definitely warranted. Why is it important to advance child-centric research in the drug development industry? Children are not small adults. There are ...

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 Share this Late Stage Research PPD’s late stage experts work closely with you to develop creative, flexible solutions to help ...

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 © 2017 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 © 2017 Pharmaceutical Product Development, LLC. All rights reserved.

Post-Approval Clinical Trial Monitoring Services | PPD

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

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 © 2017 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 Share this Clinical Development Services in Japan PPD-SNBL, one of the largest clinical development service providers in Japan, was formed when PPD entered into a joint ...

Cardinal Health Regulatory Sciences

7400 W 110th St., 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 ...

R&D Services Pharma Consulting

10519 Reeder St. Overland Park, KS 66214 Tel: 913-481-4309

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ABOUT US — R&D Services

... mid-size pharma and biotech companies in their development efforts from the preclinical to early clinical stages. Our scientists are experienced in a wide ...

Dr. Gregory M. Kochak — R&D Services

... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ... nanotechnology. He has experience in discovery, preclinical, and clinical drug development including Phases 0/I, I, and II. Besides ...

Dr. Thomas N. Thompson — R&D Services

... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ...

OUR SERVICES — R&D Services

... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ... metabolism and drug interactions, pharmaceutical technology, pharmacokinetics and ... in drug development both within Pharma and the CRO industry work ...

R&D Services

... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ... mid-size pharma and biotech companies in their development efforts from the preclinical to early clinical stages. Our scientists are experienced in a wide ...

PUBLICATIONS — R&D Services

... consulting services in drug discovery, preclinical and early clinical drug development to small and medium size companies who have ... Pharmacol. 2011 Sep; 68 (3):593-601 The clinical significance of drug ... in Drug Development, Vol 3. Peter Bonate and Danny Howard, editors. ...

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... the lead optimization to the preclinical and early clinical development phases, RDS provides laboratory qualification, study design, placement ... the lead optimization to the preclinical and early clinical development phases, RDS provides laboratory qualification, study design, placement ...

Quay Pharma

Quay House, 28 Parkway Deeside Industrial Park Flintshire 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 ... industrial experience in chemistry, analytical chemistry, preclinical and ... pharmaceutical manufacturing and quality assurance. The Quay advantages ...

Services - Quay Pharma

... bring drug products through the various stages of clinical development quickly and cost effectively. Quay Pharma have the ... how Quay Pharma is ideally placed to help develop orphan drug products Clinical trial supply Quay Pharma provides comprehensive primary and ...

What we do - Quay Pharma

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

Quay Pharma to supply promising cancer drug for trial - Quay Pharma

... s range of services includes early stage (pre-clinical) formulation development, novel drug delivery design, analytical R&D development, stability testing, and clinical trial manufacture, commercial manufacture and packing of new ...

MHRA approval of Quay Pharma's GMP manufacturing suites - Quay Pharma

... s range of services includes early stage (pre-clinical) formulation development, novel drug delivery design, analytical R&D development, stability testing, and clinical trial manufacture, commercial manufacture and packing of new ...

KTP funding supports specialised oral dosage development - Quay Pharma

... extensive range of services includes early stage (pre-clinical) formulation development, novel drug delivery design, analytical R&D development, stability testing, and clinical trial manufacture and packaging of new drug compounds. ...

Global Orphan Drug Congress - Quay Pharma

... to take your non sterile project from pre-clinical formulation development all the way through to small scale commercial ...

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 ...

Development of a novel drug delivery system for use in controlling the spread of aids - Quay Pharma

... the vaginal tablets are being assessed in extensive clinical trials. This development seems likely to be a very significant milestone ...

BioMed 2015 Conference in Tel Aviv, Israel - Quay Pharma

... Pharma’s services range from pre-formulation, formulation development, clinical trial manufacturing and packaging through to niche commercial scale manufacturing. Representing Quay Pharma will be Professor Mike ... and David Sykes (Business Development). If you would like to meet with Quay ...

Orphan drugs - Quay Pharma

... to deliver an Orphan Drug molecule from pre-clinical and formulation development all the way to small scale commercialisation. As ...

Phase I clinical manufacturing - Quay Pharma

... clinical manufacturing We are extensively involved in the development of early clinical formulations and clinical manufacturing of First in Man trials, and can develop a formulation specifically designed to achieve your targets ...

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: ...

Quay Pharma is awarded Eurostars funding for oncology project - Quay Pharma

... process, two compounds will be taken through pre-clinical trials, and then be developed further for First In Man studies. Quay’s ... bio-availability for both molecules during the pre-clinical phase. In ... selected for the development of in vivo efficacy models, a French partner ...

Bioavailability enhancement using lipidic system - Quay Pharma

... the bioavailability of a drug, seriously inhibiting its clinical efficacy and potential for development. Over 40% of new drug substances exhibit poor ...

Who we work with - Quay Pharma

... Quay has expertise in cold chain distribution of clinical supplies. Quay has developed a novel HIV treatment used to combat the spread of AIDS in Africa. Quay has local representative in Japan working with major pharmaceutical companies. Clinical material is supplied to Australia as part of ...

New packing and distribution facility further enhances Quay offering - Quay Pharma

... formulation development, novel drug delivery design, analytical method development and clinical trial manufacture. « Back to listing Leave a Reply ...

News/Events - Quay Pharma

... to Quay’s service offering now allows for development from late pre-clinical through to commercial … New additions join the expanding ... their resources on marketing products, rather than discovery, development and ... $168bn … Clinical trials expertise delivers the right flavour Date: May ...

Developing a flexible targeted delivery system - Quay Pharma

... phases of release required were For the early clinical trials, it was important to develop a system that allowed flexible dosing, because the ...

Clinical trials expertise delivers the right flavour - Quay Pharma

... is a specialist outsourcing company for formulation, analytical development and subsequent clinical trials manufacturing for pharmaceutical and biotechnology companies worldwide, ...

AXIM announces that the company’s product development partner is Quay Pharma - Quay Pharma

... charge of managing the entire project including the clinical strategy and trials. “We are excited to move forward the development of MedChew Rx pharmaceutical chewing gum with our ...

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 ...

Analytical Services - Quay Pharma

... factor of our success in early stage formulation development, stability studies and clinical trial manufacture. Analytical and quality control services include: ...

Commercial manufacture and packaging - Quay Pharma

... Quay Pharma’s service offering now allows for development from late pre-clinical through to commercial manufacture. The application ran in ...

Quay Pharma's commercial license granted - Quay Pharma

... to Quay’s service offering now allows for development from late pre-clinical through to commercial manufacture and was put in ...

Quay expands it's management team further - Quay Pharma

... the development and characterisation of oral formulations for clinical trial (GMP) and commercial applications for new drugs. His role at MSD involved the development of complex, innovative formulations and processes to assess ...

Preformulation and Preclinical Studies - Quay Pharma

... strategy designed to help your drug progress into clinical use. Our preformulation capabilities include: Is your drug showing poor solubility or bioavailability? Formulation development Got an enquiry? Click here to get in ...

Approaches to Phase I Development - Quay Pharma

... clinical stage all the way through the various clinical phases. Quay Pharma also partners with some of the top 20 larger pharma and biotech companies. Quay Pharma’s Head of Pharmaceutical Development, Mike Frodsham , recently presented at InForm, in Barcelona. ...

Technologies - 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 ...

Corporate Archives - Quay Pharma

... further enhancing its range of services to support clinical trials with the ... development and production will drive global revenues for contract ...

Comparison of different formulations prototypes - Quay Pharma

... drug progressed to Phase I (First in Man) clinical studies. There were two ... were concerns about development costs, and a limited budget for the early ...

Solubility and bioavailability enhancement - Quay Pharma

... techniques are required to to turn them into clinically effective products. Class 4 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 ...

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 ...

Redx Pharma has hired Quay Pharma to manufacture supplies of a drug to tackle cancer - Quay Pharma

... treat cancers. Quay Pharma, which specialises in contract development, ... clinical candidate, both scientifically and commercially. This class of ...

Conventional dosage forms - Quay Pharma

... We are also used to working with formulations developed by clients or other ... the barriers to clinical progress. We can also provide a range of ...

Modified release technologies - Quay Pharma

... life cycle in the market. Others arise from clinical considerations like the importance of taking a drug ... the gastrointestinal tract. All of the formulations we develop are provided to clients with full Intellectual Property ...

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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.

Sound science, innovative medicine and results-oriented client service Worldwide Clinical Trials is a global leader ...

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. - 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 ...

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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 ...

Almac Group

20 Seagoe Industrial Estate Almac House Craigavon Tel: 21-56-6085-00

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... and manufacturing drug product for all phases of clinical trials. Analytical Services: Delivering comprehensive solutions supporting drug substance and drug development programmes, including Chemistry, Manufacturing and Controls (CMC) regulatory ...

ProCepT

Industriepark Rosteyne 4 Zelzate Tel: +32-(0)-9-342 23 23

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4M8-TriX | ProCepT

Modular Concept for R&D and Clinical Development Our product matrix allows customers to combine multiple processing units with a single central control system, central air handling and auxiliary equipment. ...

ProCepT News

... system. A unique process module for galenic and clinical development in Agglomeration / Drying / Coating. The investment , by centralizing ... save time and costs in cleaning validation for clinical development. technologies and processes are transparent by combining glass ...

ProCepT News

... can also go one step further and offer clinical production (Phase I & IIA). is more than 15 years innovative in development of process technology with expertise in Particle Engineering ...

ProCepT News

... application of the unit from R&D to Clinical batches. Contact us for our Feasibility Lab Services and Consultancy in process development and technology transfer to pilot and production scale. ...

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Modular Concept for R&D and Clinical Development Our product matrix allows customers to combine multiple processing units with a single central control system, central air handling and auxiliary equipment. ...

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