Life Sciences Consultancy

Seagull – Life Sciences Consultancy

Our Services

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