Outsource / Partner Manufacturing

Outsource/Partner Manufacturing Services

Selecting Your Development and Manufacturing Partner & Negotiating Terms

To get your product into clinical trials as soon as possible, it is essential that the best contract development and manufacturing partner be selected and a comprehensive set of agreements be negotiated.

  • Identification and qualification of potential partners
  • Preparation of Request for Proposals (RFPs)
  • Evaluation of proposals
  • Negotiation of the supply agreement
  • Negotiation of the quality agreement

Process Technology Transfer

Transfer of manufacturing process technology to a outsource/partner site is a significant undertaking, one that needs to be accomplished quickly and efficiently. Skillful integration of all of the relevant project components is required, which may include:

  • Creation of an effective technology transfer team, with representatives of relevant functions within each organization
  • Use of professional project management tools to ensure to ensure on-time and on-budget delivery
  • Creation and tracking of all project documents to support effective technology transfer and to ensure cGMP compliance
  • Integration of your quality systems with those of the manufacturing organization
  • Creation of validation master plans and protocols for utility systems, analytical procedures, process equipment and manufacturing processes
  • Creation and filing of US or European regulatory documents related to the manufacture of clinical or commercial products