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 contact person for pharmacovigilance in the BeNeLux
- Local literature screening
- We have subscription to 100+ local journals in the BeNeLux and France that are not indexed in international databases
- Local literature screening
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