Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which ap

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importa

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abound

A guide to make your Enterprise Risk Management program effective and to avoid the most common mis-steps. Examines the four most common mistakes in existing Ent

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), B