Pharmaceutical Regulatory Affairs
Language: English
Published by Notion Press, 2026
- Hardcover
- New

Seller: PBShop.store UK, Fairford, GLOS, United KingdomPBShop.store UK
AbeBooks seller since June 11, 1999
Condition: New
US$ 61.43
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- Title
- Pharmaceutical Regulatory Affairs
- Author
- Putta Ravi
- Publisher
- Notion Press
- Publication year
- 2026
- Condition
- New
- Binding
- HRD
- Language
- English
- ISBN 13
- 9798907224193
- Item weight
- 948 grams
Pharmaceutical development is governed not only by scientific discovery, but by the regulatory evidence required to establish quality, safety, efficacy and responsible clinical use. Written for B.Pharm Semester VII students under the PCI 2026 framework, this textbook develops Regulatory Affairs as an applied pharmaceutical discipline linking drug development, regulatory decision-making and protection of public health.The text progresses from regulatory principles, terminology and major authorities to drug discovery, non-clinical evaluation, regulatory documentation and clinical development.
It examines CDSCO and State Licensing Authorities in India, international agencies including the US FDA, EMA and PMDA, IND, NDA and ANDA pathways, Drug Master Files, bioequivalence, generic and phytopharmaceutical regulation, CTD, eCTD and ACTD submissions, overseas registration and post-approval changes. Clinical research phases, IRB and IEC functions, informed consent, Good Clinical Practice, trial monitoring and pharmacovigilance are integrated within the wider product lifecycle.
Clear explanations emphasise why regulatory requirements exist, how evidence is generated and documented, and how regulators use that evidence in review and approval. Jurisdiction-specific concepts are carefully distinguished, while historical provisions are placed in appropriate context.
"Synopsis" may belong to another edition of this title.
PBShop.store UK
Fairford, GLOS, United Kingdom
AbeBooks seller since June 11, 1999
Shipping rates from United Kingdom to U.S.A.
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