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Regulatory affairs

SAFETY TESTING SERVICES INC

http://www.consult-toxicology.com

STS specialized in toxicology and preclinical regulatory affairs. It provided consulting services for the design, conduct, reporting and evaluation of toxicity and other safety testing studies. Its objective was to help its clients bring their best potential products to market in a cost efficient manner and well within their patented time frame. This ensured the necessary return on investment and provided funds for developing future compounds. STS was dedicated to helping companies maintain reasonable yet practical research and development budgets. Knowing the constraints placed upon its clients by today's regulatory requirements and market conditions STS concentrated on providing the most effective support services. STS was headed by Barry E. Osborne, PhD, who had spent more than 32 years in toxicology and other safety testing research, working in three major contract research laboratories (two in the UK, one in Canada) and establishing a new and successful testing laboratory in Frederick, Maryland, USA. During this period he gained "hands-on" experience in the design, performance, reporting and evaluation of all relevant types of toxicity studies. Broad knowledge of international testing regulations and Good Laboratory Practices (GLP's) was acquired and research programs undertaken on a broad range of pharmaceutical, biotechnology products, chemicals and biomaterials. Extensive travel throughout N. America, Europe and Asia provided him with the necessary understanding of the needs of not only multinational companies but also new and emerging companies whose resources tend to be more limited. During the past additional 8 years Dr. Osborne also developed expertise in preclinical regulatory affairs. Further information can be obtained by contacting: JOY OSBORNE, SAFETY TESTING SERVICES INC., 2639 BELMONT, ST. LAZARE, QUE., J7T 2A1, CANADA. Tel: 450-458-1613 Fax: 450-458-4137 E-Mail: toxozzy@consult-toxicology.com

  • 12/8/2013
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Life Scientific Ltd

  • 12/8/2013
  • 5
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Pharma Medica Research Inc.

http://www.pharmamedica.com

Pharma Medica Research Inc. provides Clinical Trials Research (Phases I-IV), Bioanalytical, Regulatory, Data Management and Statistical Services to Innovative and Generic Pharmaceutical and Biotechnology companies worldwide. At the forefront of the North American CRO industry, our reputation is built upon: High Quality service on time…..every time! Innovation and Responsiveness Integrity and Reliability Regulatory Compliant without Compromise Pharma Medica Research Inc. is dedicated to building long term relationships with its clients by providing quality data at a competitive price through its exceptionally capable and dedicated team of scientific and business professionals.

  • 12/8/2013
  • 6
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Origin Pharmaceutical Services Ltd

http://www.originpharm.com

Origin is an international contract product development company that provides services in Product Development, Regulatory Affairs, Clinical Research, Pharmacovigilance, Data Management, Statistics, Medical Writing and Quality Assurance. Formed in 1999, we have offices in the UK, Germany, France, and the US, and support clients across Europe and Japan. Our experience spans a broad range of therapeutic areas and we can provide expertise in several specialist fields, including orphan indications, biotech products, vaccines and paediatrics. A service to suit you Whatever the project, we provide the appropriate level of expertise and resource to fit your needs, either working at our own offices or supplying full- or part-time staff to give support on site. We,re here to make your life easier, so when we say we,ll do something, we do it. That,s why so many of our clients come back to us time and time again, confident that we,ll deliver exactly what we,ve promised, on schedule and within budget. By discovering Origin, not only do you find the support you,ve been looking for, but also a company you can rely on.

  • 12/8/2013
  • 5
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ClinStat , Inc.

http://www.clinstat.ca

CLINSTAT is a Canadian contract research organization (CRO) which specializes in web based data entry applications, regulatory affairs (NHPs and pharmaceuticals - Canada), and clinical program evaluations. We are flexible, easily accessible and customer focussed. The activities of the company are carried out through two Divisions:

  • 12/8/2013
  • 5
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Target Health Inc

http://www.targethealth.com

Target Health Inc., a full-service e*CRO, is committed, through creative collaboration, to serve the pharmaceutical community with knowledge, experience, technology and connectivity. Our pledge is to optimize the life cycle of drugs, biologics and devices with expertise, leadership, innovation and teamwork. We provide superior, consistent performance with a cutting edge, diverse team with the highest standards of ethical conduct and integrity. Target Health Inc. is a privately held, New York City based full service e*CRO with staff dedicated to all aspects of Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Internet-Based Clinical Trials (EDC, electronic data capture), Software Development, Strategic Planning and Drug and Device Development. Target Health Inc. also has a group of specialized advisors in the areas of Toxicology, Analytical Methods Validation, Product and Process Development, Quality Assurance and Manufacturing. Over the past 5 years, Target Health Inc.. performed data management and biostatistics for 3 approved NDAs and one approved PMA. Two of the approved NDAs and the PMA used Target e*CRF®. Target Health's proprietary internet-based clinical trial software for electronic data capture, data management and project management. In 2007, 1 NDA, 1 BLA and 1 PMA will be submitted which used Target e*CRF Target Health Inc. submits approximately 3 original INDs per year, 3 4 510(k)s and currently represents 17 companies at FDA and 2 companies at Health Canada. Target Health Inc. clients include Fortune 100 companies as well as many smaller companies.

  • 12/8/2013
  • 5
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Anapharm Inc

http://www.anapharm.com

Anapharm is an industry leader in early-phase drug development, providing a wide range of services to the pharmaceutical, biotechnology, and generic-drug industries. Anapharm offers a vast array of bioanalytical laboratory services, as well as services in Phase I clinical development, bioequivalence, and regulatory affairs. As a PharmaNet Development Group company, Anapharm has access to a global network of resources for Phase I-IV consulting and clinical drug development.

  • 12/8/2013
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Note

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