Facility setup & transfer
Facility set up
- Strategy and design of facility (e.g.: clean room, material flow, etc.)
- Compliance with regulations
- Tissue handling (receiving to final packaging)
Facility transfers
- Develop strategy and transfer plans (e.g.: adapt from old facility, invent in new facility)
- Establish manufacturing equivalency of the old and new site with minimal testing (cost saving, time and resources)
- Regulatory filings
Facility Consolidation
- Develop consolidation strategy
- Identify areas that needs to be addressed (e.g.: equipment used for testing, solutions, materials / equipment needed)
- Demonstrate compliance (minimize testing via rationales)
- Regulatory filing and approvals
