We provide a focused approach to the pharmaceutical clinical development of drugs, devices biologics for regulatory submissions.
Archive for October, 2010
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GxP (GMP, GCP, GLP) & Regulatory Consultancy
We provide rapid, comprehensive effective advice to clients on a broad range of regulatory & technical issues
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OCT
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Experience with all phases of product development.
Pre-clinical, clinical CMC, CRO oversight, regulatory interactions, document preparation, review & filings.
Recent Publications and Presentations
We are proud to provide updates on the current activities of our consortium of experts. To view the current news, presentations and publications of our consortium, you will need Abobe Acrobat Reader to view the files online.
Jeffrey Barrett, Ph.D.
Quantitative Pharmacology in a Translational Research Environment
Optimizing Event-driven Clinical Trial Efficiency with Discrete Event Simulation
Richard Lowenthal, M.S., M.S.E.L., has over 17 years of Regulatory Affairs and Quality Assurance experience in various roles at both small and large pharmaceutical and biotechnology companies. Lowenthal has extensive experience with strategic global development as well as product registration of new drugs and biologics in the United States, Europe and Japan.
Mark Staples, Ph.D., has more than 20 years experience with the product development and project management of proteins and peptides formulations for the pharmaceutical and biotechnology industries.