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
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- Local contact person for pharmacovigilance in the BeNeLux
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- 24/7 availability
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- Monitoring of national and EU pharmacovigilance legislation and regulations – with reporting of regulatory intelligence updates to the clients as applicable
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- Monitoring of the safety profile of the products of the MAH locally
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- Function as contact point between the EU QPPV of the MAH and the NCA
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- Collecting, recording, and reporting of safety information – according to the client specifications and in accordance with the regulatory requirements
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- Performing follow-up activities for ICSRs – with translation of the pharmacovigilance correspondence between HCP and MAH when needed (English/French/Dutch/German)
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- Local contact person for pharmacovigilance in the BeNeLux
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- Local literature screening
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- We have subscription to 100+ local journals in the BeNeLux and France that are not indexed in international databases
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- Local literature screening
Quality Assurance Services
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- Responsible person (GDP), Qualified person (GMP)
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- Applications for Wholesale Distribution Authorisations and Manufacturing and Importation Authorisations
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- Supporting national health authority inspections: preparation, management and follow-up
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- 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
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- Compassionate Use and Medical Need Programs
Information and Publicity services
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- Review and approval of information and publicity
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- Certification of product information translations
Regulatory Affairs services
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- Review of product information: translations in local languages (Dutch, French, German), review of translations
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- Regulatory Intelligence in the BeNeLux