Regulatory Compliance Solutions

Message from 14-October-2026

We are excited to announce that Farma Service has joined Infarama, an independent Belgian pharmaceutical consultancy specialising in Regulatory Affairs, Pharmacovigilance and Quality Assurance.
This partnership expands our expertise and capabilities while ensuring continuity for all clients, contacts and ongoing projects.
We look forward to building this next chapter together.

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