Author Description

As pharmaceutical and biologics manufacturers market more products worldwide, regulatory professionals need to know how to develop a strong regulatory strategy to support and maintain product registration. This book specifies key strategic elements, from the core team to submission to postmarketing. If your company is going global, this book is an invaluable resource. This is the first book of its kind, focusing on multinational pharmaceutical and biologics product regulatory strategy. Major topics include clinical trial application and design, CMC strategies, regional regulatory requirements, major regulatory authorities and lifecycle management. Who Should Use This Publication? This is a must-have for all new professionals entering the field of regulatory strategy. It provides insight from regulatory experts on global regulatory strategy that could help you better reach your corporate goals in a more effective and cost-efficient manner.