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Harnessing AI at regulators: How the FDA and EMA are innovating AI use

How Early Regulatory Input Strengthens CDMO Selection and Project Success

Key Takeaways from the Palleos Webinar on EU Clinical Trials

From Bench to Bedside: Nonclinical data requirements to initiate first-in-human studies of ATMPs

BIO KOREA 2025 – Building a Healthier World Together

Easter Lunch

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World Health Day and World Parkinson’s Day

Navigating the Evolving Regulatory Landscape of ATMPs and Medical Devices

New on Our Website: Smart Navigation & Support!

EMA Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms

No ASMF Procedure for Biological Drug Substances? Here’s What You Need to Know

Human Medicines in 2024 (overview)

FDA Updated Guidance on Nitrosamine Impurities

Regulatory challenges in the classification of drug-device combinations

One standardized icon set for clearer medication information

EMA Updates Post-Approval Application Guidance Effective 1 January 2025

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

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