Understand when and how to effectively write a PSUR for your medical devices according to European Regulation (EU) 2017/745.

Understanding the nuances of the classification of medical devices according to European regulation is a crucial step for biotechnology...

INTRODUCTION: In the constantly evolving world of medicine and pharmacology, the emergence of biosimilars represents a significant...

INTRODUCTION "I invite you to explore the primary challenges and opportunities in research and development (R&D) within the medical...

Advice on Tools and Resources for Regulatory Medical Writing in R&D Processes for Rare Diseases.