What We Do

We provide compliance solutions and consultancy services for medicinal products for human and for veterinary use, medical devices and other healthcare products.

Regulatory Affairs

  • Life-cycle management for medicinal products and medical devices
  • Review of product information: translations in local languages (Dutch, French, German), review of translations
  • Assistance and review of technical files
  • Regulatory intelligence in the Benelux

Quality Assurance

  • Review of procedures and processes for compliance with good distribution practices (GDP) guidelines and good manufacturing practices (GMP) guidelines
  • Assistance with the preparation, management and follow-up of national health authority inspections
  • Temperature mapping of warehouses and transportation vehicles
  • Compliance review and gap analysis with medical device regulations
  • Audits of suppliers and service providers, internal audits, preparation, management and follow-up of customer audits
  • Review of quality and technical agreements
  • Responsible person (GDP), qualified person (GMP), 24/7 availability

Information and Publicity

  • Review and approval of information and publicity
  • Certification of translations


  • Local contact person for pharmacovigilance in the Benelux
  • 24/7 availability
  • Local literature screening: we have subscriptions to 50+ local journals in the Benelux and France that are not indexed in international databases

Other Healthcare Products

  • National registration of food supplements
  • National registration of biocides