Combinate BioWorks
Audits and inspection readiness.
Internal, supplier, CMO, and regulatory inspection-readiness audits across pharmaceutical, medical device, and combination product operations.
Audit services.
Quality-system audits
- Internal quality-system audits
- Combination product audits21 CFR Part 4, QMSR, and drug-device interfaces
- Supplier and external-partner auditsCMOs, contract laboratories, and service providers
- Audit-program and CAPA effectiveness reviews
Inspection readiness
Medical devicesPMAInspection readiness
DrugsPAIPre-Approval Inspection
BiologicsPLIPre-License Inspection
Scope, criteria, sites, participants, and reporting expectations are agreed before the engagement. Supplier approval, product release, and regulatory-agency representation remain outside the service.