Regulated roles · Belgium and the Benelux
Regulatory affairs and quality assurance consultancy for Belgium and the Benelux.
MEDCOR is the independent consultancy of Hendrik Staels, an industrial pharmacist accredited as Qualified Person, Responsible Person and Responsible Person for Information and Publicity.
Work directly with the person who carries the responsibility.
Independent since 2018, with over ten years in regulatory affairs and quality assurance, MEDCOR supports pharmaceutical, medical device, cosmetics and food supplement companies across Belgium, Luxembourg and the Netherlands, working directly with the FAMHP and other national authorities.
When you engage MEDCOR, you work directly with the person who carries the responsibility. There are no account layers and no junior hand-offs. You get senior regulatory and quality judgement, and a single point of accountability from the first call to the final sign-off.
How I can help
Start with the role or service below to see which one fits your requirement best. If you are not sure, that is fine. Get in touch with your specific requirement and we will work out how best MEDCOR can serve your needs.
Regulatory Affairs (RA) Consultant, Belgium and BeneluxActing as your ad interim Regulatory Affairs Manager for medicinal products, medical devices, detergents and food supplements, from marketing authorisation applications through renewals and variations.Read more 
Responsible Person for GDP (RP), Belgium and BeneluxActing as your Responsible Person for wholesale distribution authorisations, covering import, purchase, warehousing and export, with Good Distribution Practice quality systems built and maintained to EU GDP standards.Read more 
Qualified Person for GMP (QP), BelgiumActing as your Qualified Person for batch certification and release, with GMP compliance support, quality management systems and audits against ISO 9001 and ISO 13485.Read more 
Responsible Person for Information and Publicity (QP-RIP), BelgiumActing as your Responsible Person for Information and Publicity in Belgium, reviewing advertising to healthcare professionals and public advertising of OTC medicines, controlling sample distribution and managing FAMHP advertising visa requests including Mdeon.Read more 
Person Responsible for Regulatory Compliance (PRRC), Medical DevicesActing as your outsourced or backup Person Responsible for Regulatory Compliance under Article 15 of the Medical Device Regulation (EU) 2017/745, overseeing device conformity, technical documentation and post-market surveillance.Read more 
ISO 9001 Quality Management System, Belgium and BeneluxBuilding, auditing and guiding ISO 9001:2015 quality management systems through to certification, starting with a gap analysis and a prioritised route to certification.Read more 
ISO 14001 Environmental Management System, Belgium and BeneluxBuilding ISO 14001 environmental management systems for companies that need to win tenders and answer ESG requirements, from a gap analysis against the current standard through to certification.Read more
Sectors I work across
Medicines
Medical Devices
Cosmetics
Food SupplementsNot sure which service you need?
That is okay, and it is often the first question I get. Tell me your situation and we will find the right fit.
Get in touch