process validation for expedited approval drugs

White Paper:

Process Validation and Regulatory Review in the Age of Expedited Approval Drugs

Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited approval drug, Chemistry, Manufacturing and Controls (CMC) data needs to be generated in about half the time of the traditional process.

Of course, an expedited approval classification does not mean that the drug developer can do less. In order to meet these accelerated timelines, analytical methods creation and product and process characterization needs to start sooner, and the process needs to be handled differently.

This paper explores those dynamics and offers some revised approach suggestions.

Download the Whitepaper

Complete the form below to download your copy!

Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes

White Paper: Navigating the European Union’s (EU) Drug Device Combination Product Regulatory ChangesThe European therapeutics market has been working to manage the upheaval caused by Brexit and is now working its way through yet another challenge: the medical devices...

Cell Therapies – Overcoming Challenges Within the Regulatory Framework

White Paper: Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory FrameworkWithin the cell therapy arena, regulators, the medical community and industry alike are often confronted with an unsettling question. What is this, really? Should a given...

mAbs and Their Therapeutic Evolution

White Paper: mAbs and Their Therapeutic EvolutionBy Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant Monoclonal antibodies (mAbs) elegant specificity has catapulted them to a starring role within the world of precision medicine over the course of...

« Older Entries