TABLE OF CONTENTS
JANUARY/FEBRUARY 2017 | VOLUME 19 | NUMBER 1
32 FDA’S QUALITY AGREEMENTS GUIDANCE
Evaluation of FDA’s recently issued, Contract Manufacturing Arrangements for Drugs:
Quality Agreements Guidance for Industry
36 CMO OVERSIGHT: WHAT IS THE CLIENT’S ROLE?
A look at the client’s role in ensuring manufacturing readiness for biopharma production at a CMO
43 ANALYTICAL TESTING OUTSOURCING TRENDS UPDATE
Spurred by many factors the global analytical testing services market is experiencing rapid growth
46 WHO WILL WIN IN PHARMACEUTICAL FINE CHEMICALS
Western pharmaceutical fine chemcials suppliers must prepare for an uncertain future
48 NAVIGATING THE SHIFTING LANDSCAPE OF CONTRACT API MFG.
What does it take for a CMO to succeed and grow in the current competitive marketplace?