| Client: | Large medical device company |
| Challenge: | After experiencing delays and setbacks associated with CMC issues during product-approval cycles, the company wanted hundreds of its researchers, engineers, and product developers to learn more about chemistry, manufacturing, and controls (CMC). |
| Outcome: | Two PharmaNet Consulting professionals, both former-FDA regulatory CMC experts, assisted the client in developing a two-day program focused on CMC. The program enabled client personnel to apply new CMC knowledge to ongoing projects and avoid pitfalls in their product pipelines. |
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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
Avoid CMC Pitfalls
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.