Do you perform independent third-party audits?

Yes. Independent third-party audits of suppliers, service providers, and partners are conducted, including GMP, GDP, ISO 13485, and GACP audits.

How are audit findings documented?

Audits are concluded with structured, written audit reports that clearly document observations, findings, and regulatory relevance.

Yes. A draft version of the audit report is provided to the client for review, including one round of factual clarification before finalization.

Yes. Data integrity principles and controls are assessed where applicable, with reference to ALCOA+ expectations.

Audits and training sessions are available in both English and German.

Yes. GMP training is provided covering fundamentals, advanced topics, inspection preparation, audit behavior, and data integrity.

Independent senior support shaped by audits, remediation, operations, and leadership responsibility.