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68 Companies with Results for clinical development 1 - 10 of 68

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 ... and prediction of drug-drug interactions 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 ... 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 ...

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 ...

PBPK Modeling Workshop | Population PK Analysis | NONMEM Workshop

... pharmacodynamics of drugs as they progress to the clinic. View Event ... a drug development program and to provide the foundation for understanding ...

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 ...

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 ...

Careers - Simulations Plus

... with our elite team of engineers and scientists developing software for ... interpret pre-clinical and clinical data. Study the effect of diseases ...

Resource Center - Simulations Plus

... Silico Strategies to Identify OATP1B1 Inhibitors and Predict Clinical Drug–Drug Interactions Journal Articles Ethanol Effects on ... Articles Nilotinib preclinical pharmacokinetics and practical application toward clinical projections of oral absorption and systemic availability Journal ...

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 ...

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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 ... modeling & simulation , and data assembly . ...

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 ...

PPD - Applying Technology in Hematology and Oncology Research

... oncology drug development and state-of-the-art clinical development technologies are driving success in clinical research. PPD ... PPD offers an integrated and seamless approach to clinical development and medical imaging for oncology research. This unique ...

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 ...

Vaccine Development Therapeutic Study Expertise | PPD

... clients’ vaccine programs. Read More Regulatory Requirements for Clinical Development of Novel Influenza Vaccines PPD regulatory and clinical development experts summarize the prevailing regulatory landscape for seasonal ...

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 ...

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 ...

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 ...

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 ...

Respiratory Therapeutic Study Experience | PPD

... insight for integrating biomarkers into asthma and COPD clinical development programs. Read More Connect With Us We want ...

Clinical Technology & Innovation Services | PPD

... class organizations to provide strategically integrated and customized clinical development services Preclarus® PPD is advancing clinical research through ...

Therapeutic Expertise | PPD

... in endocrine / metabolic indications. Gastroenterology More than 800 clinical development professionals worldwide with experience in gastroenterology protocols. Hematology & ...

PPD - Hematology and Oncology Expertise

... 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.

PPD Recognized for Leadership in Clinical Research

... to collaborate with contract research organizations (CROs) on clinical development programs. PPD’s comprehensive offerings range from integrated ...

Gastroenterology Therapeutic Study Experience | PPD

... Our team includes more than 900 hands-on clinical development professionals worldwide with experience in gastroenterology protocols, many with clinical trial experience across multiple indications. Our close working ...

Pharmaceutical, Biotechnology, Medical Device and Government Industry Expertise | PPD

... access to a team of experts specializing in clinical development and program management, with a unique understanding of ... development. As competition and regulatory requirements for device development ... global clinical trials across six continents. PPD® Biotech Since its ...

PPD Laboratories Functional Service Partnerships (FSP)

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

Event Calendar

... www.cbinet.com/conference/pc17167 Get Directions CHINATRIALS Clinical Development Leaders' Summit Kerry Hotel Pudong No.1388 Hua ...

Principal Officers | PPD

... David Johnston, Ph.D. Executive Vice President, Global Clinical Development Ed Murray Executive Vice President and Chief Human ...

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, ...

Acurian Announces Hiring of Tom Privette to Lead Global Business Development

... in pharmaceutical and biotech management as well as clinical research and development,” said Roger Smith, Acurian’s senior vice president ... in India. He also has held senior business development and clinical research positions with another global contract research organization ...

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 ...

Immuno-oncology Experience - PPD

... More Austin Combest, Pharm.D., BCOP Senior Director, Clinical Science and Information Global Product Development Read More Andy Kinley, Ph.D. Director, Feasibility ...

PPD Clinical Research Associates Recognized for Excellence

... recognition demonstrates the high caliber of PPD’s clinical research associates and PPD’s award-winning training and development programs, such as the Virtual Clinical Foundations Program ...

Infectious Diseases Therapeutic Study Experience | PPD

... Microbiology Laboratory Services PPD Laboratories' central lab supports clinical trials worldwide in infectious diseases drug development through our laboratory testing services and expanded capabilities ...

Neuroscience Therapeutic Clinical Research Expertise | PPDi.com

... is moving at a rapid pace with shortening development times, PPD’s clinical team and medical professionals are prepared to step ... expertise across a broad range of disorders, our clinically trained ... drug development experience in the areas of neurology, psychiatry, pain ...

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 ...

CRO Overview | PPD

... provides an overview of the drug discovery and development process. What are clinical trials? What does a CRO do and how does it work with a pharmaceutical, biotechnology, medical device, academic or ... Drug Development page includes easy-to-understand information on the ...

PPD - Innovation in Hematology and Oncology

... PPD’s commitment to hematology and oncology drug development can be seen through our clinical support of 28 approved hematology and oncology drugs ... and how clients can better prepare for global development programs. ... Clinical Trials Through properly conducted feasibility studies, PPD can ...

Become a Clinical Trial Investigator with PPD

... Investigator Why Become a Clinical Trial Investigator As clinical trial investigators, physicians play an integral role in the development of medicines. 1 2 3 4 Sign up ...

Critical Care Therapeutic Study Experience | PPD

... comprehensive services. We understand the unique nature of clinical studies in a critical care environment and ensure the quality of your development program through: We have conducted more than 16 ...

Media Kit | PPD

... Strategy We are committed to bringing scientific and clinical expertise, quality, and speed to every drug discovery and development program to help deliver safe, effective products to ...

Hematology and Oncology Therapeutic Study Experience - PPD

... guide our clients through all phases of drug development. Discover PPD Experience Advanced Clinical Technologies Advanced Clinical Technologies We're turning data ...

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 ...

News Releases | PPD

... Excellence PPD announced industry accolades earned by PPD clinical research associates (CRAs), recognizing their expertise in the endeavor of developing life-changing medicines. 08 Jun. 2017 PPD Recognized ...

Participate in a Clinical Trial | PPD

... and effectiveness. Become a Clinical Trial Investigator As clinical trial investigators, physicians play an integral role in the development of life-changing medicines. Connect With Us We ...

News and Events Information for PPD

... 25 May. 2017 PPD Recognized for Leadership in Clinical Research 23 May. 2017 Acurian Announces Hiring of Tom Privette to Lead Global Business Development See all news PPD In The News Get ...

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 ...

http://www.ppdi.com

Menu Careers © 2017 Pharmaceutical Product Development, LLC. All rights reserved. Share Login Privacy Policy Our Approach to Privacy Clinical and medical research are founded upon the collection and analysis of the most confidential information about people. Individuals will only share ...

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, ...

Dermatology Therapeutic Study Experience | PPD

... drug (IND) briefing packages to preparing multiphase product development plans and from assembling new drug applications (NDAs) to providing biostatistical analyses. We have conducted 86 clinical studies in dermatologic indications involving more than 20, ...

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 ...

Company History | PPD

... constant innovation to speed the overall execution of clinical trials. ... and time curve of drug development. Connect With Us We want to hear from ...

PPD Privacy Policy

... Share this Privacy Policy Our Approach to Privacy Clinical and medical ... Development, LLC and its affiliates (together “PPD”) recognize that ...

Healthy Clinical Trial Volunteers for Phase I Trials - PPD

... of the capabilities of the PPD Phase I clinic, view our online tour. Read ... © 2017 Pharmaceutical Product Development, LLC. All rights reserved. Google+

Blog

... standards group, and Denise Sackner, director of early development services ... in clinical innovation, discusses the use of industry data standards, ...

Phase II-IIIb Clinical Trial Volunteers - PPD

... who can provide you guidance on finding a clinical trial that is appropriate ... © 2017 Pharmaceutical Product Development, LLC. All rights reserved. Google+

Endocrine and Metabolic Therapeutic Expertise | PPD

... Unique Needs At PPD, we’re committed to developing flexible and customizable solutions that fit the specific needs of clients of any size for any study in any region. We help clients prepare for success by providing strategic clinical study design planning, ranging from smaller consulting contracts ...

Volunteer for a Clinical Research Study | PPD

... Yourself While Helping Others PPD conducts medically supervised clinical studies with healthy volunteers (Phase I studies). Listen ... past PPD participants. STUDY VOLUNTEER OPPORTUNITIES Phase I Clinic PPD's Phase I clinic in Austin, Texas, ...

Phase I Study Volunteer Opportunities | PPD

... IN A TRIAL Menu Contact Us Share this Clinical Trial Volunteer Opportunities Research Studies at the Austin Clinic The following table lists selected current and upcoming ...

Clinical Data Management Services | PPD

PARTICIPATE IN A TRIAL Menu Share this Clinical Data Management Partner for Data Management Results PPD’s clients can employ the technology, processes and expertise that best meet the needs of ...

PPD In The News

... Denise Sackner write about the impact of increased clinical trial complexity on project management. Applied Clinical Trials (June 2017) PPD expands Virginia vaccine lab ...

Immunology Therapeutic Study Experience | PPD

... its history and has conducted more than 120 clinical studies in immunologic and rheumatologic indications involving approximately ... led by a board-certified rheumatologist. Immunology Global Clinical Trial Experience We have global clinical trial experience ...

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... large molecule biologic drugs. Dr. Reitsma has extensive clinical development experience, having joined PPD in 2010 from MedImmune, where he served as vice president of clinical development since 2004. At MedImmune, he led the company’ ...

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 ...

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 ...

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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. Benefits of Crystalomics Technology Back to top

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 ...

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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 ...

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. ...

Pharmatek

7330 Carroll Rd San Diego, CA 92121-2364 Tel: 858-805-6383

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Pharmatek | Seminars & Speaking Engagements

... small molecules from early stage preclinical research to clinical development Challenges with poorly soluble compounds The workshop is ... characteristics of your compound with your corporate goals, clinical timelines and development budget. There will be a live Q&A ...

Pharmatek | Webinars

... He has a broad background in preclinical through clinical drug development and GMP manufacturing. He possesses a strong knowledge ... He has a broad background in preclinical and clinical drug development and manufacturing of small molecules and peptides. Mr. ...

Pharmatek: Product Development Strategies for Poorly Soluble Compounds

... Peptides. He has broad background in preclinical through clinical drug development and GMP manufacturing. He possesses a strong knowledge ...

Pharmatek | Bench to Clinic Fast

... characteristics of the compound and your corporate goals, clinical timelines and development budget. We offer several strategies to expedite product development for first in man clinical testing, including: When conventional formulation technologies are not ...

Featured Face at Pharmatek – Nathan Barksdale | Pharmatek Capsule

... Peptides. He has broad background in preclinical through clinical drug development and GMP manufacturing. He possesses a strong knowledge ...

Pharmatek | Injectable Development

... Toxicology Formulation Development & Stability Studies with GLP support •Clinical Formulation Development & Stability Studies •Container/Closure & Delivery Component Compatibility Studies • ...

Part 3: The “Most Interesting” Campaign | Pharmatek Capsule

... development, Rina’s expertise lies within preclinical and clinical formulation development and manufacturing of injectable dosage forms for small ... focuses on quality control for stability studies and clinical dosing returns. ... your injectable development projects, wouldn’t you want them on your ...

Featured Face at Pharmatek – Rina Fong | Pharmatek Capsule

... and development. Her expertise is in preclinical and clinical formulation development and manufacturing of parenteral dosage forms for small ...

Pharmatek | Formulation Development

... characteristics of the compound and your corporate goals, clinical timelines and development budget. Pharmatek Laboratories, Inc. Latest Post Twitter Feed © ...

Pharmatek | GMP Manufacturing

Once a clinical formulation is developed, the decision of where to manufacture clinical supply is critical to maintaining product development timelines and ensuring product ...

Pharmatek | Highly-Potent Development

... challenges of limited data availability at the pre-clinical and phase I/II development stages. For instance, many compounds in the early ...

Pharmatek | Orphan Drugs

... market and return on investment. Our Bench to Clinic Fast© approach to development and client-centric mentality makes Pharmatek an ideal ...

Pharmatek | Early Phase Development

... preclinical toxicology formulation development and accelerated early phase development programs to Clinical Trial Materials (CTM) supply and scale-up, Pharmatek ...

Pharmatek | Past PTEK U Seminars

... the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial ...

Pharmatek | Compound Characterization

... compound has what it takes to get through development to human clinical trials. Understanding a compound’s “druggability” is critical to creating a strategy for formulation and manufacturing development. Compound “druggability” is measured by the solubility of ...

Pharmatek | Clinical Packaging, Labeling & Distribution

... to working with multiple suppliers. Pharmatek’s integrated development services seamlessly move your project from production to packaging, distribution, storage and stability with ease, reducing your overall clinical material costs and time to clinic. The Pharmatek ...

Pharmatek | Topical

... Methods Development & Testing • Compound Characterization & Preformulation Testing • Formulation Development • GMP Manufacturing • Clinical Packaging, Labeling & Distribution Have Questions For A Pharmatek ...

Pharmatek | Preformulation Testing

... analytical methods provide the scientific backbone on which clinical formulations are based. The supporting data generated during these studies is fundamental to a successful development program and can impact: Have A Questions For ...

Pharmatek | Bioavailability Enhancement

... goal is to match the best technology for clinical success with our client’s corporate goals, timelines and budget. The approach towards formulation development involves first assessing simple formulations and increasing the ...

Pharmatek | IND Enabling Tox

... site to replicate and administer • Building upon the development of a human formulation If needed, Pharmatek can produce non-clinical formulations for shipment to testing facilities. We can ...

Pharmatek | Pharmatek to Present at the 9th Annual Clinical Suply Forum on Early-Phase Drug Product Strategies for Oral Dosage Forms

Pharmaceutical Development and Manufacturing ... © Copyright - Pharmatek Laboratories, Inc 2016 Top

Pharmatek | Characterization & Preformulation

... analytical methods provide the scientific backbone on which clinical formulations are based. The supporting data generated during these studies is fundamental to a successful development program. The Pharmatek Difference Each drug candidate is ...

Pharmatek | Company Overview

... peptide drug candidates from the bench to the clinic. Pharmatek’s Services Our experience includes first-in-man strategies, solutions for poorly soluble compounds, controlled release formulations and dedicated facilities for the development and manufacturing of highly-potent compounds . Pharmatek’s ...

Pharmatek | Poorly Soluble

... goal is to match the best technology for clinical success with our client’s corporate goals, timelines and budget. Click here to learn more about Pharmatek’s formulation development capabilities. Contact us today to learn about Pharmatek ...

Pharmatek | Peptides

... a smoother journey from the bench to the clinic. Our Peptide Experience Includes: ... Approach to Development We base our approach to formulation and analytics ...

Prototype Stability | Pharmatek Capsule

... product that has undergone thorough analysis from prototype development to the finished dosage form to ensure the clinical success of our client’s projects. To learn ...

Pharmatek | PTEK U Seminar Series

... such as analytical chemistry, preclinical drug development, formulation development, GMP manufacturing, toxicology, pK/ADME, drug safety, design of clinical trials, regulatory affairs, and drug delivery and pharmaceutical ...

Pharmatek | Small Molecules

... API Characterization & Preformulation Testing • Analytical Methods Development • Formulation Development Dosage Forms Supported • Solid & Liquid Oral • Injectable • Topical • cGMP Manufacturing • Stability Storage & Testing • Clinical Packaging, Labeling & Distribution Our experience includes first-in- ...

Pharmatek | Analytical Methods Development

... a drug candidate relies not only on its clinical merit but also on the ability ... development efforts. At Pharmatek, the focus on analytical excellence ...

Pharmatek | Pharmaceutical Development and Manufacturing

... Welcome to Pharmatek We are a pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. At Pharmatek, we’re focused on driving compounds from the bench to the clinic with the simplest, most effective formulation and manufacturing ...

Quality Metrics | Pharmatek Capsule

... are present in every step of the drug development process from the data we generate and the products we manufacture to the reports we produce and the on-time delivery to the clinic. We strive to provide services that our clients ...

Pharmatek Capsule |

... Read More About Rina Lyophilization In Parenteral Formulation Development, when a ... clinical profiles… Watch The Video Quality Metrics By continuously ...

Pharmatek | Tradeshows & Conferences

... here for more information about this event Global Clinical Supplies Group US Conference April 25-27, 2016 ... click here for more information about this event Clinical Trial Supply Southern California November 4-5, 2015 ...

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... peptide drug candidates from the bench to the clinic. Our capabilities include: • Formulation & Analytical Development • cGMP Manufacturing • Clinical Packaging, Labeling & Worldwide Distribution Our ...

HTD Biosystems

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

View company website

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

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