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Windsor Framework – Changes to the licensing of medicines for human use in the UK (and affecting Northern Ireland)

Unlocking Innovation with EMA’s Innovation Task Force

The International Recognition Procedure (IRP) for Medicinal Products in the UK

Understanding the Differences Between Medical Devices with Ancillary Substances and Substance-Based Medical Devices

Seamless Transition to eCTD in Ukraine: Discover Our Services

Sharing the power of teamwork!

Revised ICH guideline Q2(R1) on Validation of Analytical Procedures

When to Submit a New 510(k) for Medical Device Changes?

Zero Day MR Procedure

New ICH guideline Q14 on Analytical Procedure Development

Regulatory Affairs is like searching for Easter eggs!

Little knowledge about the influence of herbal remedies on medicines

Top 10 Deficiencies in New Applications for a Certificate of Suitability (CEP)

Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform

Goodbye

Are 6-month chronic toxicity studies always necessary for nonclinical safety assessment of therapeutic monoclonal antibodies?

Dutch Agency MEB expands options for Planning Tool for requesting time slots

Unlocking Potential: The Vital Role of GSPR in Medical Device Development

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

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