Outsource/Partner Manufacturing Services

SELECTING YOUR MANUFACTURING PARTNER AND NEGOTIATING TERMS

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

• 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

BioPharm Process Associates
50 Crest Road
Piedmont, CA 94611

(510)-985-0336 Telephone
(510)-985-0337 Fax