| Client: | Small Italian pharmaceutical company specialized in licensing products and marketing them in Europe. |
| Challenge: | Evaluate completed study data for possible in-licensing of two products that had reached phase III clinical development: one for Parkinson's disease and one for benign prostatic hypertrophy. |
| Outcome: | A PharmaNet team comprising representatives from Medical Affairs, Regulatory Affairs, Biostatistics, and Pre-clinical Consulting reviewed the available product data, evaluated the acceptability of completed studies, and recommended additional studies required for successful European registrations. The team's cost-analysis of the recommended programs enabled the client to decide on the clinical viability of the programs and whether to in-license the products based on the required investment. |
 |
||
 |
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. |
 |
 |
||
Clinical and Product Development
Key Product Areas
Chemistry/Manufacturing Controls
Quality Assurance/Quality Control
Evaluating In-Licensing
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.