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, led by a senior 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. Over ten years of experience, one point of contact, and extra capacity when a project needs it.
Three roles
RP, QP and RIP held personally by Hendrik, with a vetted specialist network behind them.
Benelux
Belgium, Luxembourg and the Netherlands, with submissions to the FAMHP.
Trusted by teams at
Work directly with the person who carries the responsibility.
You deal with me from the first call to the final sign-off. Alongside me works a network of vetted regulatory and quality specialists, each chosen for a particular field. When a programme grows, a deadline tightens or a specialist topic comes up, the right expertise joins the work and it keeps moving.
Specialist in regulatory affairs or quality assurance? Join the MEDCOR network →
Not sure which role or service you need? That is often the first question I get, and a good place to start.
Hendrik StaelsPharmD · Qualified Person · MBA
How I can help
Regulatory AffairsMarketing authorisations, renewals and variations for medicinal products, including submissions to the FAMHP.
Pricing and ReimbursementMarket access for medicines in Belgium: price applications and RIZIV/INAMI reimbursement files for vaccines, generics and other medicines.
Responsible Person for GDPGDP licences covering import, purchase, warehousing and export, including customs warehouses and local invoicing guidance.
Qualified Person for GMPBatch certification and release, GMP compliance and audit programmes for medicinal products.
Information & PublicityResponsible Person for Information and Publicity (N°949). Validation of advertising to healthcare professionals and public advertising of OTC medicines.
Person Responsible for Regulatory CompliancePRRC under Article 15 of the Medical Device Regulation (EU) 2017/745, for MDR devices.
CE Marking of Medical DevicesQualification, classification, technical file review, notified body selection and EUDAMED, Swissdamed and UK registration under the MDR (EU) 2017/745.
ISO 9001 Quality ManagementBuilding and auditing ISO 9001 quality management systems and guiding them through to certification, gap analysis first.
ISO 14001 Environmental ManagementISO 14001 environmental management systems for companies that need to win tenders and answer ESG requirements, through to certification.
Areas of expertise
Core areas
- Regulatory Affairs for medicinal products, 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, including pricing and reimbursement of medicines.
- Medical Information for prescription and OTC medicines, devices, cosmetics and supplements.
- CE marking of medical devices under the MDR (EU) 2017/745, from classification to EUDAMED registration.
- Product Claims across medicines, medical 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).
- Qualified Person, recognised by Belgian Royal Decree (N°2216).
- Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the MDR (EU) 2017/745.
Sectors I work across
Medicines
Medical Devices
Cosmetics
Food SupplementsSelected experience
GDP quality systems
Setting up 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
Building ISO 9001:2015 quality management systems from the ground up, particularly for medical device distributors navigating mergers and acquisitions.
What clients say
“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.”
“Great service! Efficient communication, great support from beginning to end of process. They are really informed and go the extra mile.”
“Thanks to his broad experience, his practical approach and drive, he helped Arseus Medical obtain its ISO 9001:2015 certificate. Not only did he obtain the official paper, more importantly he changed the attitude and the way we now work in the organisation.”
“Very professional and competent. Client service is excellent, with a quick response to your questions. Very good cooperation and very pleasant to work with!”
“Excellent company and the preferred partner to work with.”
“Hendrik took on the Responsible Person role for our wholesale distribution licence. Our GDP system is now solid, the authority inspection went smoothly and we finally have peace of mind.”
“From supplier qualification to temperature excursions and recalls, Hendrik handles GDP with real expertise. As our RP he is always reachable and decisions are taken quickly.”
“As our Responsible Person for Information and Publicity, Hendrik reviews every promotional piece carefully and quickly. Our campaigns stay compliant without slowing the business down.”
Not sure which role
you need?
Send a short message about your situation and we can work out which one fits.
staelshendrik@medcor.be