Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation and the philosophy underlying the policies and presents policies and standards that can be used as presented or adapted to individual situations in your company. Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation and the philosophy underlying the policies and presents policies and standards that can be used as presented or adapted to individual situations in your company.