Know where you stand.
Before they do.
Independent, system-based audits — and practical support to close the gaps before an inspector finds them.
System-Based Facility GMP Audits
Comprehensive audits covering facilities, utilities, process equipment, laboratory instruments, computerized systems and the QMS — with a gap analysis, improvement recommendations and follow-up of their implementation.
GMP Audit Preparation & Support
Audit strategies for regulatory, customer or third-party inspections: preparing internal expert teams, running mock audits and providing on-site support during the inspection itself.
Vendor Qualification & GMP Audits
Planning, execution, reporting and follow-up of audits at domestic and international API manufacturers, critical service providers and contract manufacturing organizations.
What an audit covers.
- Facilities
- Utilities
- Process equipment
- Laboratory instruments
- Computerized systems
- QMS
- API manufacturers
- CMOs
Walk into your next inspection prepared.
Regulatory, customer or third-party — let’s build the strategy together.