“Austria has particular requirements for obtaining a license for manufacturing, distribution, import and marketing of medicinal products. Our experienced team already supported many well-known companies in successfully achieving the required license.”


QM SYSTEMS / INSPECTIONS / LICENSES.

We establish and maintain your tailor-made quality management system.

Quality management is an absolute necessity to survive as pharmaceutical company nowadays. The competent authority undertakes inspections to monitor the compliance with your quality standards. We guide you on your way to and through the inspection.

Austria has particular requirements for obtaining a license for manufacturing, distribution, import, and marketing of medicinal products. We already supported many companies in successfully achieving the required license.

Our experienced team helps you with:

  • Preparation of facility inspections
  • Preparation of pharmacovigilance inspections
  • Application of a manufacturing/operating license pursuant to § 63 AMG
  • Creation of the Site Master File
  • Complete QM system set-up of adjustment of your existing system to local requirements
  • Training
  • Completing the required official forms
  • Creation of organization charts incl. job description
  • Creation of the Site Master File
  • Submission to authorities
  • Assistance during inspections
  • Support during follow-up of authority inspections until granting of the license

Third Party Audits

  • GMP audits
  • Pharmacovigilance audits

Have a question concerning QM Systems, Inspections & Licences? 

Contact
Dr. Ingrid Huber-Strubl