Pharmaceutical Regulatory Affairs

By Saurav Suryavanshi

In the fast-evolving world of pharmaceuticals, regulatory affairs form the backbone of safety, compliance, and global market access. Without a clear understanding of regulatory requirements, even the most groundbreaking drugs cannot reach the patients who need them.

“Pharmaceutical Regulatory Affairs” by Saurav Suryavanshi is a comprehensive guide that simplifies this complex field. Written for students, professionals, and industry aspirants, it bridges theory with practical applications—equipping readers to confidently navigate the regulatory landscape.

Inside, You’ll Discover:

• The foundations of pharmaceutical regulations and compliance

• Global regulatory frameworks: FDA, EMA, CDSCO, and more

• Drug development stages and approval processes

• Key documentation: IND, NDA, ANDA, CTD, and eCTD

• Post-marketing surveillance and pharmacovigilance

• Career opportunities and skills required in regulatory affairs
  
  

Clear, concise, and career-focused, this book serves as both a learning resource for students and a reference guide for working professionals in pharma, biotech, and clinical research.

Whether you are just starting your journey or advancing your expertise, this book will help you master the principles of regulatory affairs and play a crucial role in bringing safe, effective medicines to the world.

Knowledge that empowers. Guidance that matters.