| Client: | Mid-sized global pharmaceutical company |
| Challenge: | Help a pharmaceutical company with no experience in biotechnology products to revise its manufacturing and regulatory processes. |
| Outcome: | PharmaNet Consulting experts in Chemistry/Manufacturing/Controls and Regulatory Affairs suggested process modifications that enabled the client to meet the requirements for a Biological Investigational New Drug. The biological recently completed initial Phase I studies. |
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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
Review and Revision of CMC Processes
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.