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Updates
New ICH guideline Q14 on Analytical Procedure Development
April 4, 2024
Updates
Regulatory Affairs is like searching for Easter eggs!
March 27, 2024
Updates
Little knowledge about the influence of herbal remedies on medicines
March 19, 2024
Updates
Top 10 Deficiencies in New Applications for a Certificate of Suitability (CEP)
March 12, 2024
Updates
Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform
March 7, 2024
Updates
Goodbye
February 27, 2024
Updates
Are 6-month chronic toxicity studies always necessary for nonclinical safety assessment of therapeutic monoclonal antibodies?
February 20, 2024
Updates
Dutch Agency MEB expands options for Planning Tool for requesting time slots
February 13, 2024
Updates
Unlocking Potential: The Vital Role of GSPR in Medical Device Development
January 17, 2024
Updates
Regulation on Health Technology Assessment (HTA)
December 12, 2023
Updates
Clinical evaluation strategy for Medical Device Software certification under MDR/IVDR
December 5, 2023
Updates
Outscoring your regulatory affairs activities? Why?
November 28, 2023
Updates
STARoDub Outing 2023
November 24, 2023
Updates
Toxicological risk assessment of mutagenic impurities
November 21, 2023
Updates
Is it possible to optimize development process of your medicinal product?
November 14, 2023
Updates
STARoDub @ BioEurope Munchen and Nordic Life Science (NLS) Days in Copenhagen
November 13, 2023
Updates
Draft guideline on the Development and Manufacture of Synthetic Peptides
November 7, 2023
Updates
Navigating EU Regulatory Compliance for Medical Devices with Ancillary Medicinal Substances
October 31, 2023
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Valentyna Starodub
Founder and Chief Executive Officer
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