PharmaNet Consulting professionals can help you design and manage an efficient manufacturing program, while keeping a watchful eye on regulatory compliance.
Our expert professionals support your Chemistry, Manufacturing, and Controls development to:
 Select the best active ingredient candidates |
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| Identify qualified vendors for cGMP manufacturing and studies of cGMP stability |
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Develop stability programs, according to ICH guidelines, for both lead and backup compounds |
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Select and manage a cGMP bulk-drug manufacturing campaign and subsequent scale-up |
| Execute stability studies to select the most-compatible excipients |
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| Determine the optimum formulation for the intended route of administration |
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| Manage the cGMP clinical-supply manufacturing campaign |
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| Prepare CMC summaries for regulatory submissions |
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| Consult on GMP training and feasibility audits |
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| Write standard operating procedures |
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| Meet with regulatory authorities on CMC issues |
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PharmaNet professionals available for consultation on this topic include:
Executive Director, PharmaNet Consulting
Executive Director, PharmaNet Consulting
Joyce Lea Frey-Vasconcells, PhD
Executive Director, PharmaNet Consulting
Vice President, Scientific and Regulatory Affairs, Anapharm
Executive Director, PharmaNet Consulting
504 Carnegie Center, Princeton, NJ 08540