• 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

Strategic

• 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