Expert insights on regulatory affairs & pharmacovigilance
Expert perspectives from the M.P.C.A. International team on Regulatory Affairs, Pharmacovigilance, GMP/GDP and market access in the Benelux — keeping you informed on the latest EU regulatory developments.
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Add your first article via WordPress dashboard → Posts → Add New. Use the categories Regulatory Affairs, Pharmacovigilance, GMP/GDP, Market Access, EU Regulations or Benelux to organise your content.
Read full articleWhat is a QPPV and why does your company need one?
Every marketing authorisation holder in the EU must appoint a Qualified Person for Pharmacovigilance. We'll explain what this means in practice.
5 common GMP audit findings — and how to avoid them
Based on our experience supporting companies through GMP inspections, here are the most frequent findings and how to address them proactively.
Market authorisation in the Benelux: national vs. European procedures
Choosing the right regulatory pathway for your product in Belgium, the Netherlands or Luxembourg? We break down the key differences.
eCTD submissions: updates and practical tips for 2025
The shift to fully electronic submissions continues. Here's what marketing authorisation holders need to know about eCTD requirements and common pitfalls.
Need help navigating the
Benelux regulatory landscape?
Our team of specialists is ready to support you — from regulatory strategy and pharmacovigilance to market access and quality assurance.