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New ICH guideline Q14 on Analytical Procedure Development

Regulatory Affairs is like searching for Easter eggs!

Little knowledge about the influence of herbal remedies on medicines

Top 10 Deficiencies in New Applications for a Certificate of Suitability (CEP)

Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform

Goodbye

Are 6-month chronic toxicity studies always necessary for nonclinical safety assessment of therapeutic monoclonal antibodies?

Dutch Agency MEB expands options for Planning Tool for requesting time slots

Unlocking Potential: The Vital Role of GSPR in Medical Device Development

Regulation on Health Technology Assessment (HTA)

Clinical evaluation strategy for Medical Device Software certification under MDR/IVDR

Outscoring your regulatory affairs activities? Why?

STARoDub Outing 2023

Toxicological risk assessment of mutagenic impurities

Is it possible to optimize development process of your medicinal product?

STARoDub @ BioEurope Munchen and Nordic Life Science (NLS) Days in Copenhagen

Draft guideline on the Development and Manufacture of Synthetic Peptides

Navigating EU Regulatory Compliance for Medical Devices with Ancillary Medicinal Substances

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

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