ABSTRACT

Because of rapid developments in the biotechnology industry-and the wide range of disciplines that contribute to its collective growth-there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a c

chapter 2|32 pages

Project Management

chapter 4|28 pages

Regulatory Compliance

chapter 5|38 pages

Quality Systems

chapter 6|62 pages

Biomanufacture

chapter 7|50 pages

Quality Control

chapter 8|40 pages

Nonclinical Studies

chapter 9|42 pages

Clinical Trials