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A First Look at the Future of CMC Documentation in ICH M4Q(R2)

EU GMP Annex 15 – Qualification & Validation, public consultation started

Roses are red. Violets are blue.Non-compliance is costly… but Starodub has got you covered.

World Cancer Day 4 February 2026

Reflecting on Human Medicines in 2025, European Medicines Agency

Artificial Intelligence and the Future of Drug Development

Stability testing for applications for variations to a marketing authorisation; revision 3 – EMA

Happy Holidays

New draft guideline on requirements for revision/renewal of Certificate of Suitability by EDQM

Ongoing Study supporting the monitoring of the availability of medical devices on the EU market

What the new Variations Regulation (2024/1701) means

Complex and Time-Consuming Regulatory Operations

Celebrating World Quality Day 2025

Practical strategies for regulatory and clinical success in the EU

Starodub Is heading to Medica in Dusseldorf 

Get ready for serious incident reporting under the AI Act

Starodub & Greijmans Regulatory Consultancy B.V. announce a new strategic regulatory partnership

Distribution of Medical Device Software via app stores

Kim Bruggink
Senior RA Consultant
Kim Bruggink

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