Regulatory Affairs

- Writing, Preparation and Submission of Drug Registration Dossiers
- Life-cycle management of medicinal products, updates, variations,
  extensions and renewals of Marketing Authorisations for nationally
  authorized procedures, MRP/DCP as well as CP
- Compilation of EU CTD dossiers, including preparation of NeeS and eCTD
- Regulatory Gap Analysis and Due Diligence Checks of registration
  dossiers (e.g. prior to license transfer)
- Medical and Scientific Translations

- Strategic Regulatory Advice, Interpretation of guidelines
  and regulatory requirements
- Scientific Advice, Expert Reports and scientific review
- Health Authority Liaison & follow-up of deficiency letters
  from Health Authorities
- SOP writing
- Medical Devices & Food Supplements


- Writing and Compilation of Periodic Safety Update Reports (PSURs),
  Risk Management Plans (RMPs), Detailed Description
  of the Pharmacovigilance System (DDPS), Pharmacovigilance
  System Master File (PSMF), including data review
- Adverse Drug Reaction (ADR) assessment and coding
- Safety database Management
- Pharmacovigilance audits (from protocol to CAPA plan)

- Pharmacovigilance Trainings
- Implementation and maintenance of local safety processes,
  including SOP writing
- QPPV Services (Qualified Person for Pharmacovigilance)
- Health Authority Liaison & follow-up of deficiency letters
  from Health Authorities
Member of Association of Veterinary Consultants - Belgian Regulatory Affaires Society - Vlaamse Dierenartsenvereniging - Orde der Dierenartsen