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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