Our consultants have over 20 years experience in the pharmaceutical industry. We will assign the most suitable consultant to your project. Our audits include:
API Manufacturere
Clinical Trial manufacture and packaging sites
3PL providers
Prepare Audit Plan - typically 2 weeks before the audit
Conduct audit, on site (1-5 days depending on the size of operation)
Audit report to include suggested CAPA Actions
Review audit responses from Auditee (free of charge)
Our Consultants can work with your site team in preparation for regulatory inspection. We have hands on experience with MHRA, US FDA.
Preparation include pre-inspection audits, action planning and support to resolve CAPAs.
Post Inspection we can help you to prepare your responses to the inspection.
We can train your staff on how to behave during the inspection, how to answer inspector's questions and how to prepare documents.
