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91 Companies with Results for clinical development 1 - 10 of 91

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 ...

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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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 ...

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 ...

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 Recognized for Leadership in Clinical Research

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

Clinical Development Services

... 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.

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 ...

Opportunities within Site Intelligence and Activation | Life at PPD

... the SIA department, which is part of global clinical development at PPD. This department takes care of the start-up phase for all PPD projects. We are involved from the ...

PPD In The News

... a series of regulatory changes and improvements on clinical development in China. Regulatory Rapporteur (July 2017) Troubleshooting Lab Operations: Be Proactive, Not Reactive Chris Forsdyke reviews systems and ... trial complexity on project management. Applied Clinical Trials ( ...

Event Calendar

... Website: http://www.eandl-conference.com/europe CHINATRIALS Clinical Development Leaders' Summit Kerry Hotel Pudong No.1388 Hua ...

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, ...

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 ...

Careers in Global Clinical Supplies | Life at PPD

... Login Careers in Global Clinical Supplies Jaucot: The clinical trial supplies environment is growing and developing. It is often difficult to assess whether our ...

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 ...

Continuous Learning and Development | Life at PPD

... to develop a career within Medical Writing? Lacey: Clinical backgrounds and an understanding of drug/device development are relevant areas of knowledge for medical writing. ...

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 ...

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 ...

Clinical Trials Las Vegas Unit - PPD

... PPD’s Las Vegas clinical research unit recruits clinical trial volunteers for a wide range of studies. For early development trials, we regularly recruit healthy volunteers age 18 ...

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 ...

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 ...

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 ...

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 ...

Going for Gold | Life at PPD

Menu Careers © 2017 Pharmaceutical Product Development, LLC. All rights reserved. Share Login Going for Gold The 2016 Clinical Spotlight Cup took place in Madrid, Spain, which is the country of the previous year’s winners. A dedicated local team ...

Blog

... key areas for today’s project manager in clinical trials Volker Hack, senior director and head of the project management standards group, and Denise Sackner, director of early development services standards, contribute their thoughts about three essentials ...

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 ...

Programmers at PPD in Manila | Life at PPD

... SAS programmer at PPD exposes me to how clinical trials work in various therapeutic areas. While programming, I have also learned a lot about in the process of drug development and approval, different experimental designs, standards of the ...

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, ...

PPD Appoints Experienced Industry Leader to Guide PPD® Laboratories

... role after having served as vice president of clinical trials, a role in which he led the company’s central laboratory, biomarker and companion diagnostic services. Previously, Fikry was with Novartis Vaccines and Diagnostics, Inc., where he developed a track record of success in a variety ...

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, ...

PPD Privacy Policy

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

http://www.ppdi.com

Menu Careers © 2017 Pharmaceutical Product Development, LLC. All rights ... Surfers Healing Camp Volunteers help nonprofit provide therapeutic day ...

Three key areas for today’s project manager in clinical trials | Blog

... of the bigger picture of the overall drug development plan, and be the “CEO” on the project in order to provide successful outcomes and to create new opportunities for clients. With the adoption of ICH E6 R2 (good clinical practice guideline) in November 2016, PMs need to ...

Career Development in Medical Communications | Life at PPD

... opportunity to know about the latest research, upcoming clinical trials and ... me to develop in many areas. Wazenegger: Be positive and flexible – ...

http://www.ppdi.com

Menu Careers © 2017 Pharmaceutical Product Development, LLC. All rights ... Program Helps Community Employees participate in charitable food delivery ...

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 ...

Track Record of Proven Success | Life at PPD

Menu Careers © 2017 Pharmaceutical Product Development, LLC. All rights ... began at PPD 15 years ago as a research assistant. He was promoted to ...

Austin Clinical Research Unit - PPD

PARTICIPATE IN A TRIAL Menu Austin Clinical Research Unit Contact Information Address: 7551 Metro Center Drive, Suite 200 Austin, TX 78744 Directions Phone Number: + 877 773 3707 Opportunities Calendar ...

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 ...

Ophthalmology Therapeutic Study Experience | PPD

... Contact Us Share this Ophthalmology PPD offers a clinical operations and therapeutic focus on ophthalmology studies with ... sites in the past five years. Global Ophthalmology Clinical Trial Experience PPD offers expertise in ophthalmic clinical ...

Blog

PARTICIPATE IN A TRIAL Menu Clinical Trial Data Bringing SDTM alive for monitoring and review Philip Bartle, an associate director in clinical innovation, discusses the use of ...

CRA Apprenticeship Videos | Life at PPD

... passion was a perfect match for PPD’s clinical research apprenticeship program. This program is the first registered apprenticeship for clinical research associates (CRAs) in the U.S. It ...

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 ...

News and Events Information for PPD

... to Guide PPD® Laboratories 08 Jun. 2017 PPD Clinical Research Associates Recognized for Excellence 25 May. 2017 PPD Recognized for Leadership in Clinical Research See all news PPD In The News ...

Team-Building in Paris | Life at PPD

... paint and brushes,” said Nathalie Giraud, director of clinical management. “The aim for me was to reinforce ... a chance for better health thanks to newly developed drugs. Topics Archive

| Blog

... and review Philip Bartle, an associate director in clinical innovation, discusses the use of industry data standards, ... Slavery Transparency Statement Privacy Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved.

Cardiovascular Therapeutic Clinical Research Expertise | PPD

... Slavery Transparency Statement Privacy Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved. The Partner of Choice ...

Urology Therapeutic Study Experience | PPD

... identify potential challenges for a viable protocol. Urology Clinical Trial Experience With global experience across multiple urology ... Slavery Transparency Statement Privacy Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved.

A Day in the Life of a Recent College Graduate | Life at PPD

... internships that are located in both business and clinical environments. Internships at PPD provide students with a ...

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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 ...

R&D Services Pharma Consulting

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

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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 ...

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. 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 ...

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 ...

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.

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. ...

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 ...

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