| Client: | Mid-sized global pharmaceutical company |
| Challenge: | A promising product was threatened by problems with establishing GMP-compliant material. |
| Outcome: | With assistance from a PharmaNet Consulting professional, a former senior-level FDA official with extensive CMC/GMP experience, the client put together a credible plan to address the formulation issue. The plan was accepted by the FDA and led to a successful NDA submission and approval. |
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In Consulting Services PharmaNet offers a comprehensive range of early- and late-phase consulting services on topics including: international regulatory affairs; scientific and medical affairs; quality; risk management; chemistry, manufacturing and controls; as well as biopharmaceutical investor issues. |
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Clinical and Product Development
Key Product Areas
Chemistry/Manufacturing Controls
Quality Assurance/Quality Control
Complying with GMP
PharmaNet Development Group, Inc.
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
© 2008 PharmaNet Development Group, Inc. All rights reserved.