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Updates
Seamless Transition to eCTD in Ukraine: Discover Our Services
June 13, 2024
Updates
Sharing the power of teamwork!
June 3, 2024
Updates
Revised ICH guideline Q2(R1) on Validation of Analytical Procedures
April 24, 2024
Updates
When to Submit a New 510(k) for Medical Device Changes?
April 18, 2024
Updates
Zero Day MR Procedure
April 11, 2024
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
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Valentyna Starodub
Founder and Chief Executive Officer
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