Regulatory GCP Compliance auditing
Our scope of services includes audits and inspection readiness assessments of companies (sponsors, vendors), investigational sites, Institutional Review Boards, and documents in different areas of pre-clinical and clinical research. We have also been involved in strategic or business development activities of clients such as due diligence programs prior to M&A decisions, internal audits, and SOP writing activities.
Audits follow the standards of ISO 19011 and the ENGAGE Optional Guideline for Compliance and Quality Systems Auditing from the European Network of GCP auditors and other GCP experts. Inspections are conducted to standards of the EMA, MHRA and FDA