DSI provides flexible, full-service project management and integrated teams of CMC and regulatory affairs experts.
Technology Transfer to a new manufacturing facility can be a time consuming activity for in-house staff of both in- and out-licensing organizations. Execution of technology transfer is time sensitive and best accomplished while key personnel and supporting documentation is readily available.
Our CMC consultants:
- Review CMC documentation for completeness
- Identify data and documentation gaps
- Draft protocols
- Review data and information
- Prepare regulatory submissions
Our technology transfer teams work side-by-side with your in-house staff providing a temporary expansion of capacity to facilitate the transfer process. This allows in-house staff to remain focused on high priority projects. While at the same time, new product programs remain on target, avoiding unnecessary time and regulatory delays.