Expert Pharmaceutical Consultancy for the Benelux Market
From regulatory strategy to full product lifecycle management — M.P.C.A. International delivers expert Regulatory Affairs, Pharmacovigilance and Quality services, tailored to the unique requirements of the Benelux pharmaceutical market.
Your dedicated pharmaceutical
partner in the Benelux
Founded in 1998 by industrial pharmacist Erika Rottey, M.P.C.A. International has built a reputation as the go-to pharmaceutical consultancy for companies seeking expert guidance on the Benelux regulatory landscape. Our highly qualified team supports you throughout the entire product lifecycle.
Our storyQuality
We operate with our own stand-alone QMS — designed to the highest pharmaceutical standards. Every service is delivered in strict compliance with EU regulations, GMP, GDP and pharmacovigilance requirements.
Integrity
We work with full transparency and professional integrity — always acting in the best interest of our clients, their products and the patients who depend on them.
Flexibility
Every pharmaceutical company has unique needs. We offer tailor-made services — from in-house placements to on-demand MPCA-Online advice — without ever compromising on quality.
Pharmaceutical services across the
full regulatory spectrum
Regulatory Affairs
European regulatory affairs consulting — from initial strategy and marketing authorisation to lifecycle management, eCTD submissions and Benelux-specific national procedures.
Learn morePharmacovigilance
EU QPPV and Local Contact Person services for the Benelux. Safety data management, ICSR processing, PSMF, literature monitoring and signal detection.
Learn moreQualified Person GMP
Experienced QPs for batch certification and release of investigational and commercial medicinal products. GMP compliance, audit programmes and inspection preparation.
Learn moreResponsible Person GDP
Responsible Person services for WDA holders — ensuring full EU GDP compliance, quality system management, staff training and self-inspections.
Learn moreResponsible Person RIP
Accredited RIP n° 656 services — validation of promotional materials, medical representative training and compliance with Belgian pharmaceutical advertising regulations.
Learn morePricing & Reimbursement
Strategic market access counselling for the Benelux. Pricing and reimbursement dossier preparation and governmental affairs to optimise patient access.
Learn moreWe operate across five
healthcare product categories
Our team covers all five categories of regulated healthcare products sold in Belgian pharmacies — across the full product lifecycle.
Medicines
Human and veterinary medicinal products — from registration to lifecycle management.
Medical Devices
Regulatory strategy and compliance for medical devices under EU MDR/IVDR.
Food Supplements
Market authorisation and regulatory support for nutraceuticals in the Benelux.
Cosmetics
EU Cosmetics Regulation compliance, CPNP notifications and product information files.
Biocides
Product authorisation and regulatory support under the EU Biocidal Products Regulation.
25 years of pharmaceutical excellence
M.P.C.A. International was founded in 1998 by industrial pharmacist Erika Rottey, who built the company on deep expertise in Regulatory Affairs, GMP/GDP and Pharmacovigilance. Today, our team of 20+ professionals — pharmacists, physicians, scientists and specialists — supports clients worldwide from our offices in Ghent.
"Never give up until the job is done and make the difference for all customers."
Quality
Stand-alone QMS, EU-compliant
Integrity
Transparent & ethical
Flexibility
Tailored to your needs
"M.P.C.A. International aspires to be your reference service partner — bringing and keeping your medicines and healthcare products in the market."
Deep-rooted Benelux expertise
with European reach
Headquartered in Ghent, we are your dedicated pharmaceutical consultancy partner for the Belgian, Dutch and Luxembourg market — with unparalleled knowledge of national regulatory requirements and European procedures.
- National procedures (BE, NL, LU) and MRP/DCP
- Medical translations in Dutch, French, German and English
- Filing with FAMHP, CBG-MEB and Santé Luxembourg
- Local Pharmacovigilance Contact Person for the entire Benelux
- eCTD publishing via EXTEDO — validated and compliant submissions
Operational territory
Ready to bring your product to
the Benelux market?
Schedule a no-obligation consultation with one of our pharmaceutical specialists. We'll assess your regulatory needs and propose a tailored approach.
Let's talk about
your project
Whether you need a Qualified Person, a full pharmacovigilance system or a regulatory strategy for the Benelux — our team is ready to help.
9051 Sint-Denijs-Westrem (Ghent), Belgium