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Ad interim Regulatory Affairs Manager

Regulatory Affairs (RA) Consultant, Belgium and the Benelux.

MEDCOR acts as your ad interim Regulatory Affairs Manager across the Benelux, for medicinal products, medical devices, detergents and food supplements. You work directly with Hendrik Staels, an industrial pharmacist with over ten years of regulatory experience and a direct working relationship with the FAMHP and the other national authorities.

Are you bringing a product to the Benelux market and need the regulatory file managed?
Does a marketing authorisation need renewing or varying, and no one in-house has the time?
Has a regulatory role fallen vacant through absence, departure or high workload?
Do you need senior regulatory judgement without adding a permanent hire?

When you need this

Companies come to MEDCOR when they are bringing a product to the Benelux market, when a regulatory file needs managing through its lifecycle, or when an internal regulatory role needs covering during a gap, an absence or a period of high workload. The work suits manufacturers and licence holders who need senior regulatory judgement without adding a permanent hire.

What this covers

  • 01Marketing authorisation applications through national, mutual recognition and decentralised procedures.
  • 02Renewals and variations to existing marketing authorisations.
  • 03Advice on national and European legislation.
  • 04Regulatory compliance support across the product lifecycle.
  • 05CESP submissions.
  • 06Artwork and labelling review.

How it works

If you have a product to bring to market or a regulatory file that needs managing, get in touch to talk it through. You work with one senior regulatory professional from first call to final sign-off, not a rotating team.

MEDCOR's other services

Have a product to bring to market?

Tell me what you are working on and we will map out the regulatory route together.

Get in touch