- Services

By: Biopro Consulting  09-12-2011
Keywords: Biotechnology Company


  • Evaluate, optimize or troubleshoot downstream processes
  • Design clinical and commercial purification processes
  • Provide Requests for Proposals (RFPs) and evaluate Contract Manufacturing Organizations (CMOs) or Contract Research Organizations (CROs)
  • Transfer technology, either to an in-house facility or outsourced facility (CMO)
  • Write, edit or review CMC sections of regulatory documents (INDs, BLAs, NDAs, CTDs, etc.)
  • Prepare responses to pre- or post-approval inspection questions
  • Write, edit or review technical reports (downstream development, process validation, viral clearance, production summaries, etc.)
  • Manage contract relationships between a company and a CMO or CRO


  • Introduce development into a research-based biotechnology company
  • Advise on decisions around development strategy
  • Assess whether to "build capability or contract out" production
  • Perform program management functions: full program or CMC team
  • Assess the "phase-appropriate" approach to GMP production (process, documentation, practices, etc.)
  • Perform Due Diligence of development and manufacturing capabilities

Additional services

  • Training sessions on development and manufacturing
  • Referrals to other consultants
  • Secure extranet for file sharing

Keywords: Biotechnology Company