Scientific and CMC Regulatory Advice - Services Examples

Development

• 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

• Regulatory advice on CMC strategy to follow during each stage of product development, including strategy to present to Authorities in Briefing documents.

Licensing

• Scientific advice on final CMC package to include in the marketing authorization, including phase 3/commercial process comparability, commercial specifications and stability programs.

• Regulatory advice on strategy to present for scientific advice briefing documents such as pre-BLA briefing documents or EU Scientific advice pre-filing

Post-Approval

• Change control worldwide assessment (US, EU, China, Japan, Canada, Australia/New Zealand, 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

Across the product life-cycle

• Support to the preparation of scientific briefing documents. This includes advice on the CMC strategy to present in scientific advice briefing documents but also preparation of the actual meetings with Authorities and meeting attendance if required