DSI provides flexible, full-service project management and integrated teams of CMC and regulatory affairs experts.

TECHNOLOGY TRANSFERTechnology 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.

CMC Development
CMC Consulting Services