About Book
This textbook serves as a comprehensive academic resource for postgraduate, and research
scholars, faculties and students, pharmaceutical professionals, and industry researchers
involved in formulation development, regulatory affairs, and manufacturing processes.
The book provides an in-depth understanding of the entire journey of a pharmaceutical
product, from conceptualization and laboratory-scale formulation to its eventual large-scale
manufacture and commercialization. A major focus is placed on the critical stages of product
life cycle management, regulatory strategies, clinical evaluation, and technology transfer
procedures—bridging the gap between R&D and commercial manufacturing.
About Author
Dr. Chintan Aundhia is Professor, Department of
Pharmaceutics, Department of Pharmacy,
Sumandeep Vidyapeeth Deemed to be University
with more than 15 years of teaching and research
experience. His research areas include Novel drug
delivery and Computer aided drug design. He has an
impressive academic record, having published more
than 75 research papers and over 30 book chapters in
reputed journals and books. His contributions to
intellectual property include one patent and six
design patents. He has actively participated in over
50 professional engagements, including seminars,
workshops, conferences, and Faculty Development
Programs. He is also the recipient of the Best Young
Researcher Award by Association of Pharmacy
Professionals for his consistent and dedicated work in
the field. He is the Life member of various scientific
and academic bodies like APTI, APP etc. He has also
contributed as a reviewer for many scientific journals.
2 Juhikaben
V. Patel
Juhikaben V. Patel is presently working as a Quality
Control scientist at Lupin Pharmaceuticals, Somerset,
New Jersey, USA. She has over 7 years of experience
in pharmaceutical Industry and Clinical research. She
has done her B.Pharm from Gujarat Technological
University and M.S in pharmaceuticals from
Harrisburg University USA. She has also done MBA in
Healthcare management from Monroe University
USA. She has worked as pharmacist in planet health,
Ahmedabad. She also achieved place in Guinness
book of world record by performing a folk dance in
June 2025. She has filed 5 patents till date, and keen
towards development of newer products for
healthcare.
3
Dr. Biresh
Kumar
Sarkar
Dr. Biresh Kumar Sarkar having total 28 years of
experience in different Pharmaceutical segments,
Pharmaceutical industry in Gujarat, W.B and became
production Manager. He has got drug
approval as competent technical staff in drug
manufacturing from Directorate of Drugs Control,
West Bengal and FDA Gujarat. Eight years in teaching
in faculty of Pharmacy and Principal in
Pharmacy College in Jaipur, Rajasthan. Presently he is
working in CCRAS since last eleven years
as Assistant Director Pharmacy. Dr. Biresh Kumar
Sarkar, completed his B.Pharm, M.Pharm
(Pharmaceutics) and M.Tech in Pharmaceutical
Technology from University College Science &
Technology, University of Calcutta. He has completed
his PhD in Pharmacy and Chartered
Chemist from Institution of Chemists (India), Kolkata.
Dr. Biresh Kumar Sarkar has published
around 76 published papers in various reputed
journals and life members with various
Pharmaceutical organizations. He was guided
pharmacy students in PhD and M.Pharm thesis.
4 Dr Ankita
Wal
Dr. Ankita Wal is a distinguished academician,
researcher, Professor, and Head of the Department
at PSIT, Pharmacy, Uttar Pradesh. With her
unwavering commitment to pharmaceutical
education and research excellence, Dr. Wal has
emerged as a pivotal figure in shaping the future of
pharmacy professionals through her academic
leadership, innovative thinking, and research-
oriented approach. She holds five patents, four of
which have been successfully commercialized. She
has completed research projects sponsored by
prestigious agencies such as the Indian Council of
Medical Research (ICMR) and the Department of
Science and Technology (DST). To date, she has
published more than 100 research papers in reputed
journals including Elsevier, Springer, and Bentham
Science, and has authored 10 books.