European Regulatory Affairs Consulting & Applications
From initial strategy development to market introduction, M.P.C.A. International provides comprehensive regulatory affairs services tailored to your exact requirements. We optimise time to market while ensuring full compliance with EU regulations.
Do any of these questions apply to you?
- Are you planning for meetings with regulatory authorities?
- Is your drug eligible for Orphan Drug status?
- Would you like to benefit from our experience in publishing managing electronic submissions?
- Are you an ASME looking to benefit from European government financial support?
- Would you like to analyse your chances to meet market access requirements in the Benelux and EU?
If you answered yes to any of these, M.P.C.A. International can help. We provide the services you need with the quality you require. From initial strategy development up to market introduction.
Talk to our RA specialistsOur regulatory affairs expertise
- QP accredited
- RIP certified
- 25+ years Benelux RA experience
- National, MRP & DCP procedures
- EXTEDO eCTD software publishing
- Medical and technical writing & translations
- In-house placement available
- MPCA-online on-demand advice
Our regulatory affairs services in detail
Our regulatory affairs services can be divided into three main areas. Each tailored to your specific needs and stage of product development.
Contract Regulatory Affairs
Comprehensive RA services from our offices in Ghent, covering the full range from initial strategy to market authorisation and lifecycle management.
- Initial strategy development
- Marketing authorisation applications & follow-up
- Variations, notifications & renewals
- eCTD publishing & validation (EXTEDO)
- Medical & technical writing (SmPC, PIL)
- Medical translations (NL, FR, DE, ENG)
- Artwork review & PIL/labelling approval
- Product database updates (pharmastatus, e-compendium)
- Communication with FAMHP, CBG-MEB, Santé LU & EMA
In-House Placements
We recognise that many clients prefer contract regulatory staff working in their own offices for easier access to documentation and greater interaction with the project team.
- Staff placed at your site (days/week or full-time)
- Flexible engagement models
- Seamless integration with your team
- Access to M.P.C.A. expertise & network
- Both short-term projects & long-term engagements
MPCA-online — on-demand advice
Some clients need ad hoc regulatory advice regularly. Our MPCA-online service gives you instant access to expert guidance. You only pay for the time it takes us to respond.
- Submit questions by email
- Rapid expert response
- Pay-per-question model
- Access to full M.P.C.A. RA expertise
- Ideal for ad hoc regulatory queries
Deep expertise in BENELUX regulatory procedures
We are especially informed about the domestic Life Cycle Management (LCM) requirements of the Belgian, Dutch and Luxembourg authorities. Our team handles filings with FAMHP, CBG-MEB and Santé Luxembourg on a daily basis.
After market authorisation is granted, M.P.C.A. International provides complete closing-off in the BENELUX territory, including completion of national closings and submission of 'notification de modification - NOMO' in Luxembourg. Once commercialised, we support and manage your regulatory files throughout their complete life cycle.
Discuss your RA projectRegulatory Affairs in the Benelux
What does a Regulatory Affairs consultant do?
Which regulatory procedures can M.P.C.A. International handle?
What is eCTD and do you prepare eCTD submissions?
Do you support both human and veterinary medicinal products?
How do I get started with a regulatory project?
Ready to streamline your
regulatory strategy?
Our regulatory affairs team is ready to support you - from initial strategy to market introduction and full lifecycle management - in the Benelux and beyond.