Since 2018
Independent practice, built on a decade of prior regulatory and quality work.
Independent since 2018. Working across Belgium, Luxembourg and the Netherlands.
Regulatory affairs and quality assurance, answered by one expert.
MEDCOR is the independent consultancy of Hendrik Staels, an industrial pharmacist acting as Responsible Person, Qualified Person and Responsible Person for Information and Publicity across the Benelux.
Pharmaceuticals, medical devices, cosmetics and food supplements. Ten years of experience, one point of accountability, from the first call to the final sign-off.
Three roles
RP, QP and RIP held personally, not delegated to a junior team.
Benelux
Belgium, Luxembourg and the Netherlands, with submissions to the FAMHP.
Trusted by teams at
Work directly with the person who carries the responsibility.
When you engage MEDCOR, 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.
Not sure which role or service you need? That is often the first question I get. That is where the work starts.
Hendrik StaelsPharmD · Qualified Person · MBA
Seven ways a senior expert can help.
Regulatory AffairsMarketing authorisations, renewals and variations for medicinal products and medical devices, including submissions to the FAMHP.
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Responsible Person for GDPGDP licences covering import, purchase, warehousing and export, including customs warehouses and local invoicing guidance.
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Qualified Person for GMPBatch certification and release, GMP compliance and audit programmes for medicinal products.
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Information & PublicityResponsible Person for Information and Publicity (N°949). Validation of advertising to healthcare professionals and public advertising of OTC medicines.
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Person Responsible for Regulatory CompliancePRRC under Article 15 of the Medical Device Regulation (EU) 2017/745, for MDR devices. EU Authorised Representative under Article 11.
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ISO 9001 Quality ManagementBuilding and auditing ISO 9001:2015 quality management systems and guiding them through to certification, gap analysis first.
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ISO 14001 Environmental ManagementISO 14001 environmental management systems for companies that need to win tenders and answer ESG requirements, through to certification.
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The full scope, in practice.
Core areas
- Regulatory Affairs for medicinal products and medical devices, from marketing authorisations to renewals and variations.
- Quality Assurance, including the setup and audit of ISO 9001 and ISO 13485 systems.
- ISO 14001 systems to support tenders with an ESG focus.
- Market Access for medicinal products and medical devices.
- Medical Information for prescription and OTC medicines, devices, cosmetics and supplements.
- Product Claims across medicines, devices, cosmetics and food supplements.
Specialised 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 MDR (EU) 2017/745.
- EU Authorised Representative for medical devices under Article 11 of the MDR.
Across four regulated worlds.
Medicines
Medical Devices
Cosmetics
Food SupplementsExperience you can rely on.
GDP quality systems
Extensive experience establishing Good Distribution Practice 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.
ISO 9001 and M&A
A proven record of building ISO 9001:2015 Quality Management Systems from the ground up, particularly for medical device distributors navigating mergers and acquisitions.
“Thanks to his pragmatic approach, he achieves great results in no time. I am very satisfied with my work with Hendrik and I recommend him.”
Dominique Vanderstraeten
Quality Assurance & Regulatory Affairs, Arseus Medical
Not sure which role
you need?
That is often the first question I get. Get in touch and I'll help you work out which one fits.
staelshendrik@medcor.be