Our Services

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

Scientific Advice, Expert Reports and scientific review

Health Authority Liaison & follow-up of deficiency letters
from Health Authorities

SOP writing

Medical Devices & Food Supplements

Pharmacovigilance

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

About us

We bridge the gap between pharmacovigilance and regulatory affairs, providing expert, custom-tailored advice to ensure full compliance with complex European legislation.

Address

Gaubergstraat 4

1570 Pajottegem

Belgium

info@vetmedico.be

Phone

+32 (0)54 58 68 16

VAT

BE 0836.690.029