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Legal Theory & Systems - Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Description

Book Synopsis: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Details

Looking for an all-in-one guide to navigate through the complex world of medical product regulatory affairs? Look no further! Introducing our groundbreaking book on Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Written by an experienced author, this comprehensive and budget-friendly resource covers regulatory affairs in all major global markets, making it your ultimate go-to reference in the field.

Whether you're a pharmacologist, bioengineer, pharma engineer, or a student pursuing a career in pharmacy, this book is an invaluable tool that provides in-depth insights into drug development, national and EU regulatory issues, and manufacturing license application and retention. We're committed to delivering the most up-to-date information on the ever-changing landscape of medical regulatory affairs.

Regulation in the USA can be a daunting hurdle for many pharmaceutical professionals. Our book addresses this head-on, covering essential topics such as CDER, CBER, marketing and manufacturing licenses. With our expert guidance, you'll gain a thorough understanding of the regulatory requirements and processes involved, ensuring compliance and success in the US market.

One of the highlights of this book is its coverage of the ICH process and Good Laboratory/Clinical/Manufacturing Practices. We understand the importance of adhering to international standards, and this book equips you with the knowledge and tools necessary to navigate through these critical aspects with confidence.

Don't miss out on this unique opportunity to expand your knowledge and stay ahead in the pharmaceutical industry. Whether you're a professional or a student, this book is your gateway to mastering medical regulatory affairs. Take the first step towards success today - order our Medical Product Regulatory Affairs book now!

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