Whilst the process of obtaining Marketing Authorization for a medicinal product in the EU is well harmonized, the quality management system and license requirements for companies handling medicinal products (manufacturing, import, distribution etc.) differ considerably between EU member states. The requirements depend mainly on the specific set-up between the involved companies and the ownership of products at the different points in time.
Achieving an optimal quality system, which fulfills EU country specific requirements and fits to your company internal strategy and processes, is mandatory for successfully achieving the required licenses and enhancing a high internal compliance. Our team, involving local expertise where necessary, supports you with any service that will benefit your existing or intended system, be it for gaining a wholesaler or import license, establishing a system according to DIN ISO 900x, DIN ISO 13485 or fulfilling GMP requirements. Our services include:
Selection of the most suitable contractors and suppliers, meeting the required quality standards is an important step. Our auditors assit in all aspects of auditing and support you for:
Third party audits
Vendor Qualification Audits
Preparation of Inspections (Mock Audits)Have a question concerning QM systems, licenses or compliance? Contact Sonja Rüdele.