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Updates
How Early Regulatory Input Strengthens CDMO Selection and Project Success
May 8, 2025
Updates
Key Takeaways from the Palleos Webinar on EU Clinical Trials
April 30, 2025
Updates
From Bench to Bedside: Nonclinical data requirements to initiate first-in-human studies of ATMPs
April 30, 2025
Updates
BIO KOREA 2025 – Building a Healthier World Together
April 23, 2025
Updates
Easter Lunch
April 23, 2025
Updates
✈️Boost Your Clinical & Regulatory Success in EU – Join Our Free Webinar!
April 8, 2025
Updates
World Health Day and World Parkinson’s Day
April 7, 2025
Updates
Navigating the Evolving Regulatory Landscape of ATMPs and Medical Devices
April 3, 2025
Updates
New on Our Website: Smart Navigation & Support!
April 1, 2025
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
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Femke Jacobs
Senior RA Consultant
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