Expert perspectives from the M.P.C.A. International team on Regulatory Affairs, Pharmacovigilance, GMP/GDP and market access in the Benelux.
Featured
Our team spent three days at CPHI Milan. Here is what stood out and what it means for companies operating in the Benelux.
Read full article
Regulatory Affairs
The CBG-MEB is modernising its registration systems: new case numbers, digital signatures and submissions only via Common Repository...
Regulatory Affairs
Biotech Act, MDR/IVDR revision, Critical Medicines Act, new EU Pharmaceutical Legislation and stricter advertising rules: five initiatives to...
GDP & Distribution
On 18 July 2026 the Council of Ministers approved the draft royal decree introducing the Stock Monitoring Tool....
GDP & Distribution
A wholesaler was refused a GDP certificate after missing agreed CAPA deadlines. Why execution, not the plan, decides...
Cosmetics
Three EU regulatory changes for food supplements and cosmetics: harmonised nutrient levels, Belgian rules, and the Omnibus VIII...
Medical Devices
From 28 May 2026 the first four EUDAMED modules become mandatory under MDR and IVDR. Here is what...
Our team of specialists is ready to support you — from regulatory strategy and pharmacovigilance to market access and quality assurance.