Pharmaceutical companies
Without a local RA department, or with a temporary shortage of capacity or expertise.
Regulatory Affairs · Benelux
Regulatory affairs consultant for the Benelux
Specialist support for marketing authorisations, lifecycle management and interaction with the Belgian, Dutch and Luxembourg authorities.
How we support you
- Preparing, submitting and managing marketing authorisation applications (national, DCP, MRP and centralised procedures)
- Variations, renewals and proactive lifecycle management of your portfolio
- Regulatory intelligence: translating new legislation into practical actions for your organisation
- Gap analyses and dossier review before submission
- Direct interaction with the authorities: FAMHP (Belgium), CBG (the Netherlands) and Luxembourg
- Support with artwork, labelling and product information
Local knowledge of the Benelux authorities
Every member state has its own procedures, practices and contact points. We combine knowledge of the Belgian, Dutch and Luxembourg authorities with the European requirements of the EMA, so your dossier is in order everywhere at once.
Who we work for
International organisations
Looking for a reliable local partner for Belgium, the Netherlands and Luxembourg.
Start-ups and scale-ups
Bringing a first product to the Benelux market and looking for guidance.
How we work together
1. Exploration
We discuss your product, timeline and goals in a no-obligation conversation.
2. Concrete proposal
You receive a clear proposal with scope, approach and planning.
3. Execution
An experienced consultant works with your team until the result is achieved.
Ready to discuss a compliance project or need?
Tell us where your team needs support. We will contact you personally.