Regulatory Compliance Solutions

Our Services

Our team provides consultancy services and compliance solutions for medicinal products for human and for veterinary use, medical devices, and other healthcare products.

Pharmacovigilance Services

      • Local contact person for pharmacovigilance in the BeNeLux
            • 24/7 availability

            • Monitoring of national and EU pharmacovigilance legislation and regulations – with reporting of regulatory intelligence updates to the clients as applicable

            • Monitoring of the safety profile of the products of the MAH locally

            • Function as contact point between the EU QPPV of the MAH and the NCA

            • Collecting, recording, and reporting of safety information – according to the client specifications and in accordance with the regulatory requirements

            • Performing follow-up activities for ICSRs – with translation of the pharmacovigilance correspondence between HCP and MAH when needed (English/French/Dutch/German)

        • Local literature screening
              • We have subscription to 100+ local journals in the BeNeLux and France that are not indexed in international databases

        Quality Assurance Services

            • Responsible person (GDP), Qualified person (GMP)

            • Applications for Wholesale Distribution Authorisations and Manufacturing and Importation Authorisations

            • Supporting  national health authority inspections:  preparation, management and follow-up

            • Compliance review and gap analysis with applicable regulations (GDP, GMP): review of processes and procedures, internal and supplier audits, quality and technical agreement.

          Responsible Physician for early access program

              • Compassionate Use and Medical Need Programs

            Information and Publicity services

                • Review and approval of information and publicity

                • Certification of product information translations

              Regulatory Affairs services

                  • Review of product information: translations in local languages (Dutch, French, German), review of translations

                  • Regulatory Intelligence in the BeNeLux