Expert services across the
full regulatory spectrum
From initial regulatory strategy to full product lifecycle management. M.P.C.A. International delivers tailor-made pharmaceutical consultancy for the Benelux market and beyond. With 25+ years of expertise, we are your trusted partner at every stage.
Our pharmaceutical services
Every service is delivered by our highly qualified team of pharmacists and scientists. In strict compliance with EU regulations, GMP, GDP and pharmacovigilance requirements.
Regulatory Affairs
From initial strategy development to market introduction. We provide comprehensive European regulatory affairs consulting and applications, tailored to the Benelux and EU requirements.
- Marketing Authorisation Applications (MRP, DCP, national)
- eCTD publishing & validation via EXTEDO
- Medical & technical writing, SmPC, PIL
- Lifecycle management & variations
Pharmacovigilance
We provide both global and local pharmacovigilance services. Acting as EU QPPV or Local Contact Person for Benelux, with full safety data management and medical evaluation.
- EU QPPV & Deputy QPPV services
- ICSR management (CIOMS reporting and XEVMPD) & MedDRA coding
- PSMF management & literature monitoring
- Signal detection & risk management plans
Qualified Person GMP
Our experienced Qualified Persons take personal and legal responsibility for batch certification and release of investigational and commercial medicinal products in EU and UK.
- Batch certification & release (IMP & commercial)
- QMS development, SOPs & CAPA systems
- GMP compliance & audit programmes
- Inspection preparation & gap analysis
Responsible Person GDP
M.P.C.A. provides Responsible Person services for wholesale distribution authorisation holders. Performed by scientists (preferably pharmacists) trained annually to EU GDP guidelines.
- RP for WDA holders under TQA
- GDP quality system management
- Staff training & self-inspections
- Recall coordination & supplier approvals
Responsible Person RIP
We hold RIP and Deputy RIP accreditations issued by the EU-BE Health Agency. Providing complete compliance support for pharmaceutical advertising and information.
- Validation of promotional materials and sample management
- Medical representative training
- Declaration of Conformity signing
- Sponsoring & congress compliance
Pricing & Reimbursement
M.P.C.A. is specialised in market access for the Benelux. Building pricing and reimbursement strategies that ensure faster patient access and optimal returns.
- Strategic market access counselling
- National pricing dossier preparation
- Reimbursement submissions
- Public & governmental affairs
We operate across five
healthcare product categories
All five categories of regulated healthcare products sold in Belgian pharmacies, covered across the entire product lifecycle.
Medicines
Human & veterinary medicinal products, from registration to lifecycle management.
Medical Devices
Regulatory strategy and compliance product technical file (PTD) for medical devices under EU MDR/IVDR.
Food Supplements
Market notification and regulatory support for nutraceuticals in the Benelux.
Cosmetics
EU Cosmetics Regulation, CPNP notifications and product information files.
Biocides
Product authorisation under the EU Biocidal Products Regulation (BPR).
Our approach to pharmaceutical consultancy
Tailor-made solutions
We don't offer off-the-shelf systems. Every service, from SOPs to regulatory strategy, is designed specifically for your company, your products and your market.
In-house or remote
We recognise that many clients prefer contract staff working at their own site. We offer in-house placements for several days a week/month, or fully remote, as well as our MPCA-online on-demand advice service.
Benelux specialists
We are especially informed about the domestic requirements of the Belgian, Dutch and Luxembourg authorities. From FAMHP to CBG-MEB and Santé Luxembourg. We know the local landscape inside out.
Not sure which service
you need?
Schedule a no-obligation consultation with one of our specialists. We'll assess your needs and propose the right approach, at no cost.