The pharmaceutical industry is subject to stringent audits, inspections and assessments. We support marketing authorisation holders and manufacturers of pharmaceuticals, excipients and packaging materials to help them reliably meet these requirements.

Safety and responsibility

In a highly regulated industry like the pharmaceutical sector, every aspect of the production of complex products with global supply chains must be documented and assessed. The results of those assessments determine whether a product is marketable and falls under the personal responsibility of the qualified person at the pharmaceutical company.

Due diligence

The value of a pharmaceutical product depends on its sustainability, as well as its current sales. We assess the status of documentation and quality management, along with the product and market situation.

QM consulting

  • Consultation regarding the implementation of quality management systems
  • Creation of SOPs
  • Risk assessment
  • Etc.

Consultation on audits and audit preparation

  • GxP audits for active pharmaceutical ingredients (API), excipients and packaging
  • Preparation for, and support during, audits
  • Execution of system audits
  • National and international