Recognizing our own weaknesses often makes us stronger. Inviting a skilled, objective third party to review your quality systems and operations is a good way to reach your goals for operational efficiency and compliance.
We can be an extension of your quality organization in times when your workload is high and you need to assure that your suppliers and contractors are meeting your quality expectations.
Collectively, we have performed hundreds of audits to help our client’s bridge gaps and strengthen their organizations.
We can assist you with the following:
- Regulatory Compliance (GXP) Audits
- Mock Pre Approval Inspections (PAI)
- Quality System Gap Analysis
- Analytical Laboratory Audits
- API Facility Audits
- Excipient Supplier Audits
Before we audit, we clarify your expectations to assure we meet your objectives. Results of our audits are fully documented in a report. Upon request, we will make recommendations for improvements and help you resolve your compliance concerns.