Overview

""Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners"" is an exhaustive resource that aims to bridge the gap between academic curricula and industry requirements in the pharmaceutical domain. The book is carefully crafted to serve as a comprehensive guide for students, academicians, and professionals seeking to master the intricacies of regulatory writing and documentation practices. It provides a thorough understanding of the key aspects of documentation, including regulatory dossiers, SOPs, validation protocols, and clinical trial documentation, as well as international regulatory guidelines from the FDA, EMA, and ICH. The book also places special emphasis on practical aspects, incorporating real-world examples, case studies, and checklists to provide a hands-on learning experience and facilitate application in professional scenarios.

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9789349562479

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Ajay Ghanshyamji Pise is a distinguished professor and invertor in the field of pharmaceutical sciences, with over a decade of experience in research, education, and innovation. He holds 10 National-International awards including the Best Teacher Award from MCOPS, Manipal University. He has presented his research work in more than 15 countries, including Singapore, Malaysia, Sri Lanka, the Netherlands, and Dubai. He has served as BOS member of RTM Nagpur University and Manipal University. As an academic mentor, He has guided over 200 individuals in starting their own ventures in Vidarbha, fostering a culture of entrepreneurship and innovation. His leadership extends to the Lifon Group, an initiative supporting farmers and unemployed youth, and his revolutionary sandalwood farming project in Chimur Vidhan Sabha, where he actively promotes the economic importance of sustainable farming practices. He has authored multiple books, published research papers in reputed International Journals, and holds patents that underscore his dedication to pharmaceutical innovation. As the founder of Lifon Healthcare, he has also pioneered the production of health drinks and natural products, leveraging traditional knowledge and modern science to promote health and well-being. His expertise and vision make him a respected figure in the pharmaceutical and healthcare industries. Sandhya Mahendra Bagde is a known academician and industry professional with a rich blend of 15 years of academic experience and 5 years of industrial expertise in the field of pharmaceutical sciences. Her extensive knowledge and dedication have positioned her as a respected authority, particularly in the domain of Pharmaceutical Regulatory Affairs. She is conducting her doctoral research in Pharmaceutical Sciences, contributing significantly to advancing knowledge in her field. Her research journey has been marked by innovation and meticulousness, leading to numerous publications in national and international journals of repute, which showcase her commitment to scientific exploration and academic excellence. Throughout her career, she has demonstrated exceptional proficiency in regulatory practices and documentation, providing valuable insights into the complexities of the pharmaceutical industry. Her industrial experience has further enriched her teaching methodologies, enabling her to bridge the gap between theoretical concepts and practical applications. As an educator, she has been instrumental in guiding and mentoring students, instilling in them a strong foundation in regulatory affairs and a keen understanding of the pharmaceutical landscape. Her dedication to fostering excellence has inspired many aspiring professionals in their academic and career pursuits. Ketki Sunil Ande is a dedicated Quality Assurance Sr. Officer at SUN PHARMA, one of India's leading pharmaceutical companies. She specializes in dossier preparation and regulatory documentation, bringing a wealth of practical experience to the field of Pharmaceutical Regulatory Affairs. He has actively contributed to advancing knowledge in her domain through the publication and presentation of her work in reputed national and international journals and conferences. Her work highlights her commitment to excellence in regulatory practices and her ability to navigate the complexities of pharmaceutical regulations with precision. In her current role, He plays a pivotal part in ensuring compliance with global regulatory standards, applying her expertise to facilitate successful regulatory submissions. Her keen understanding of documentation processes and attention to detail make her a valued professional in the pharmaceutical industry.

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