Commercialization and pre approval inspection readiness
Commercialization and PAI readiness for small biotech moving toward a BLA or NDA.
Systems and processes for commercialization
Systems and processes QFS has stood up include a Medical Information hub, TraceLink, SLIMStat, post market adverse event monitoring, batch disposition, supplier qualification management, and internal and external audit management.
What a pre approval inspection covers
Readiness for commercial manufacturing, conformance to the application, and data integrity, including supplier qualification.
Data integrity review
Who can change records, audit trails, unique logins, backups and validation status, checked system by system.
Supplier and CDMO readiness
Supplier qualification and CDMO audits ahead of the filing.
Mock PAI
A multi area mock inspection with storyboards and a remediation roadmap.
FAQ
- What does FDA look for in a pre approval inspection?
- Readiness for commercial manufacturing, conformance to the application, and data integrity, including supplier qualification.