Regulatory Affairs and Quality Assurance for the Benelux

Independent since 2018, with over ten years of regulatory affairs and quality assurance experience across the Benelux. MEDCOR is the independent consultancy of Hendrik Staels, an industrial pharmacist who acts as Responsible Person, Qualified Person or Responsible Person for Information and Publicity for pharmaceutical, medical device, cosmetics and food supplement companies in Belgium, Luxembourg and the Netherlands.

Work Directly with Your Regulatory Expert

When you engage MEDCOR, you work directly with the person who carries the responsibility. Unlike a larger firm, there are no account layers, no junior hand-offs and no being passed between consultants. You get senior regulatory and quality judgement, and a single point of accountability from the first call to the final sign-off.

Core Areas of Expertise

- Regulatory Affairs for medicinal products and medical devices, from marketing authorisations to renewals and variations, including submissions to the FAMHP
- Quality Assurance, including the setup and audit of ISO 9001 and ISO 13485 systems for medicinal products and medical devices
- ISO 14001 systems to support tenders with an ESG focus
- Market Access for medicinal products and medical devices
- Medical Information for prescription and over-the-counter medicines, medical devices, cosmetics, biocides and food supplements
- Product Claims for medicines, medical devices, cosmetics, biocides and food supplements

Specialised Regulatory and Compliance Roles

- Responsible Person for GDP licences, covering import, purchase, warehousing and export, including customs warehouses
- Responsible Person for Information and Publicity (N°949)
- Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the Medical Device Regulation (EU) 2017/745
- EU Authorised Representative for medical devices under Article 11 of the MDR

Experience You Can Rely on

MEDCOR has extensive experience establishing Good Distribution Practice (GDP) quality systems for multinational companies running local commercial and sales offices in the Benelux, including guidance on local invoicing practices to help mitigate tax-related challenges. MEDCOR also has a proven record of building ISO 9001:2015 Quality Management Systems from the ground up, particularly for medical device distributors navigating mergers and acquisitions.

Sectors I Work Across

Medicines, Medical Devices, Biocides, Cosmetics, and Food Supplements

Get in Touch

Not sure which role or service you need? That is often the first question I get. Get in touch and I'll help you work out which one fits.