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  • Updates

“Medical” in medical devices: the often-forgotten element
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Don’t let GSPR be the weakest link in your MDR submission
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Quality, Operations & Improvement services
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EU eCTD Update – Implementation of Module 1 v3.1.1 & Validation Criteria v8.2
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EU-Japan Biotech Mission & BioJapan 2025
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Selection of non-clinical models for ATMP development
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BioEurope Vienna 3 – 5 November 2025
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Have you explored our white paper on the nIVD MA ToC yet?
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Understanding new post-market surveillance requirements for medical devices
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Palleos and Starodub Announce Strategic Partnership to Streamline Regulatory Pathways for Clinical Trials
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Starodub B.V. is heading to China!
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Festival of Biologics 30 September – 2 October 2025, Basel
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Beyond Pride Month: Building Inclusion Every Day
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GMP Guidelines: Rapid advancement of digital technologies and the implementation of AI
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First Joint Clinical Assessments (JCAs) begin under EU HTA Regulation
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Unified Quality Management Systems
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Major Changes Ahead for CTD Modules 2 & 3: ICH Releases Draft M4Q(R2) for Public Consultation
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Nonclinical safety assessment with New Approach Methodologies (NAMs): partner with us for regulatory success! 
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Konstantin Simočenko
Senior RA Consultant
Konstantin Simočenko

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