Scientific advice on QC release specifications, stability programs, characterization of cell and seed bank systems, viral clearance, process validation, product comparability during Phase 1 to Phase 3
Scientific advice on final CMC package to include in the marketing authorization, including phase 3/commercial process comparability, commercial specifications and stability programs.
Licensing
Regulatory advice on strategy to present for scientific advice briefing documents such as pre-BLA briefing documents or EU Scientific advice pre-filing
including strategy to present to Authorities in Briefing documents.
Post-approval
Change control worldwide assessment (US, EU, Asia, WHO, International Countries) for biological products
Scientific advice on strategy for comparability demonstration pre-post change
Management of compliance remediation programs, including definition of remediation and submission strategy and meeting with Authorities
Regulatory advice on CMC strategy to follow during each stage of product development.
