Regular on-site review of suppliers and service providers, as well as periodic evaluation of internal processes by an independent quality assurance unit to ensure quality, are core elements of the QM system in the GxP-regulated environment.
The corresponding regulations can be found in § 11 AMWHV, in the EU GMP guidelines Part I and II, in ICH E6 (R2), as well as in the GDP guidelines.

Our trained auditors have several years of professional experience in various GxP-relevant areas and are happy to support you in the planning, execution, and follow-up of external and internal audits (self-inspections).