Topics & Projects

Whitepaper · MedTech

AI in MedTech (AI Act & MDR) New

A structured guide for manufacturers of AI medical devices: interplay of AI Act, MDR and IVDR.

Training · Live Online

GMP AI Compliance Training Waitlist

Validation of AI systems in GMP-regulated environments — regulatory requirements, use cases and practical implementation.

Event · Amsterdam · May 2026

Biosimilar Medicines Conference 2026

Strategic conversations on biosimilar market access, EU pharmaceutical regulation and industrial resilience.

Expertise · GMP

CQV of GMP Facilities

Commissioning, qualification and validation of pharmaceutical manufacturing facilities — structured, efficient and audit-ready.

Series · MDR / IVDR

Regulatory Briefing Series

Concise briefings on the most important regulatory developments in medical devices and in-vitro diagnostics.

Assessment · MedTech / IVD

eArchive Readiness Check

Is your organisation ready for eArchiving? A structured assessment of your current compliance status against EU regulatory requirements.

Expertise · Biotech

From Lab to Scale

The five critical challenges for biotech start-ups on the way from the lab to industrial-scale production.