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  • Updates

EU eCTD Update – Implementation of Module 1 v3.1.1 & Validation Criteria v8.2
  • Updates

EU-Japan Biotech Mission & BioJapan 2025
  • Updates

Selection of non-clinical models for ATMP development
  • Updates

BioEurope Vienna 3 – 5 November 2025
  • Updates

Have you explored our white paper on the nIVD MA ToC yet?
  • Updates

Understanding new post-market surveillance requirements for medical devices
  • Updates

Palleos and Starodub Announce Strategic Partnership to Streamline Regulatory Pathways for Clinical Trials
  • Updates

Starodub B.V. is heading to China!
  • Updates

Festival of Biologics 30 September – 2 October 2025, Basel
  • Updates

Beyond Pride Month: Building Inclusion Every Day
  • Updates

GMP Guidelines: Rapid advancement of digital technologies and the implementation of AI
  • Updates

First Joint Clinical Assessments (JCAs) begin under EU HTA Regulation
  • Updates

Unified Quality Management Systems
  • Updates

Major Changes Ahead for CTD Modules 2 & 3: ICH Releases Draft M4Q(R2) for Public Consultation
  • Updates

Nonclinical safety assessment with New Approach Methodologies (NAMs): partner with us for regulatory success! 
  • Updates

Our 2025 company outing was unforgettable
  • Updates

MEB Planning Tool Mandatory from 1 July 2025
  • Updates

ICH Q1A Guideline – Stability Testing of Drug Substances and Products – open for consultation
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Kim Bruggink
Senior RA Consultant
Kim Bruggink

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