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Regulatory Affairs: A Comprehensive Guide for Drug Development and Approval

Author(s): Miss. Priyanshi Goyal Mr. Dharmesh Kumar Mr. Yadvendra Singh Thenuan Miss Neha Gupta
363

  • Language:
  • English
  • ISBN13:
  • 9789369265848
  • ISBN10:
  • 9369265848
  • Format:
  • Paperback
  • Trim:
  • 6x9
  • Pages:
  • 128
  • Publication date:
  • 08-Jul-2025

  •   Available, Ships in 3-5 days
  •   10 Days Replacement Policy

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"Regulatory Affairs: A Comprehensive Guide for Drug Development and Approval" serves as a vital reference for pharmaceutical professionals and students. It outlines regulatory processes from development to post-marketing, covering GMP, GCP, CTD/eCTD, and global authorities like FDA and EMA. The book ensures compliance and supports successful product approvals.

Miss. Priyanshi Goyal

Miss. Priyanshi Goyal

Miss Priyanshi Goyal is currently serving as an Assistant Professor at the School of Pharmacy, Mangalayatan University, Aligarh, Uttar Pradesh. She completed her B.Pharm from Dr. A.P.J. Abdul Kalam Technical University, Lucknow, and M.Pharm in Pharmaceutics from Galgotias University, Greater Noida, where she is also pursuing her Ph.D. With one year of academic experience, she has made significant contributions to pharmaceutical research.
Mr. Dharmesh Kumar

Mr. Dharmesh Kumar

Mr. Dharmesh Kumar, Assistant Professor in Pharmaceutics at Mangalayatan University, recently completed his M.Pharm in Pharmaceutics. With a strong interest in formulation development and nanotechnology, he actively engages in research, teaching, and academic development, aiming to inspire innovation and critical thinking among students.
Mr. Yadvendra Singh Thenuan

Mr. Yadvendra Singh Thenuan

Yadvendra Singh Thenuan is an Associate Professor at MIPER, Mangalayatan University, Aligarh, with over a decade of experience in the pharmaceutical industry and academia. A two-time Best Faculty Award recipient, he has published research papers, book chapters, and holds national and international patents in pharmaceutical sciences.
Miss Neha Gupta

Miss Neha Gupta

Miss Neha Gupta is an Assistant Professor at Aligarh College of Pharmacy, Uttar Pradesh. She holds a B.Pharm from Mangalayatan University and an M.Pharm in Pharmaceutics from Dr. A.P.J. Abdul Kalam Technical University.

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