QM Systems, Licenses & Compliance

WE ESTABLISH AND MAINTAIN TAILOR-MADE QUALITY MANAGEMENT SYSTEMS SUITED TO YOUR NEEDS, SUPPORT YOU WITH YOUR EU ESTABLISHMENT AND HELP YOU WITH SELECTION AND SUPERVISION OF YOUR CONTRACTORS AND SUPPLIERS

- Sonja Rüdele Head of QM Systems, Licenses & Compliance / Food and Hygiene Technologist

QM Systems, Licenses & Compliance

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:

  • Background information on the system and license requirements in the EU member states
  • Strategic advice on the optimal solution for your company (including Brexit considerations)
  • Complete system set up or adaptation of your existing system for a principal with several subsidiaries in several EU member states
  • System set up or adaptation of your existing system for a single company in one EU member state
  • Support during implementation of your system
  • Training
  • Compilation and submission of applications for the required licenses including follow up with the authorities
  • Mock inspections and support during inspection preparation
  • Support during inspection
  • Support during follow up of authority inspections until granting of the intended license(s)


Auditing

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

  • GMP audits for drug substances and products, including investigational medicinal products and supply chains (with special experience in Asia)
  • GDP audits for warehouses, distributors, and supply chains
  • GLP audits for safety, pharmacology, toxicology, human and animal bioanalytical studies, as well as other studies conducted under GLP
  • GCP audits for CROs, study sites, and other vendors, including central labs and drug repositories
  • Pharmacovigilance audits

Vendor Qualification Audits

Preparation of Inspections (Mock Audits)

Have a question concerning QM systems, licenses or compliance? Contact Sonja Rüdele.