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Updates
EMA Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms
March 27, 2025
Updates
No ASMF Procedure for Biological Drug Substances? Here’s What You Need to Know
March 18, 2025
Updates
Human Medicines in 2024 (overview)
March 11, 2025
Updates
FDA Updated Guidance on Nitrosamine Impurities
March 4, 2025
Updates
Regulatory challenges in the classification of drug-device combinations
February 27, 2025
Updates
One standardized icon set for clearer medication information
February 18, 2025
Updates
EMA Updates Post-Approval Application Guidance Effective 1 January 2025
February 12, 2025
Updates
Updates on eCTD Submissions for the EU: Are You Ready?
February 7, 2025
Updates
How ready are you for MDR submission?
January 28, 2025
Updates
Regulatory Affairs: A Marathon of Dedication and Strategy
January 10, 2025
Updates
Looking Back on Milestones and Forward to the Future
December 18, 2024
Updates
Interpretation of Well-Established Technology (WET) under the EU MDR
December 11, 2024
Updates
Medical Devices with Coatings: Impact on Classification
December 5, 2024
Updates
From Formatting to Submission: End-to-End eCTD Support
November 29, 2024
Updates
AI in Medical Devices: Key Highlights of the New Team NB Position Paper
November 25, 2024
Updates
Public consultations on package insert and labelling policy
November 15, 2024
Updates
Starodub is attending Medica 2024
November 7, 2024
Updates
Exciting News from Starodub!
November 6, 2024
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Cornelis Jansma
Senior RA Consultant
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