Blog

November 10, 2020

Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and TIME, can make you or break you) it can be harder to bounce back.
October 27, 2020

What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission

The FDA’s regulatory requirements for process validation highlights the need for defining Critical Process Parameters (CPPs) based on Critical Quality Attributes (CQAs). As described by the FDA, a CQA is a characteristic within a range that ensures a specified level of product quality. These requirements highlight the focus of QbD, or Quality by Design. The ICH describes this view of quality assurance that focuses more on validating the process through control parameters and less on defining quality based on product testing.
September 24, 2020

A Storybook Approach for A Successful End of Phase II (EOP2) CMC Meeting

Ideally, even before the research phase, you should study the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s web site (and below), and determine how your organization can best meet those requirements. Companies that devote disciplined, systematic attention from day one move far more efficiently toward opening trials than companies who chose to delay.
September 1, 2020

How to File an Invincible IND Application

Ideally, even before the research phase, you should study the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s web site (and below), and determine how your organization can best meet those requirements. Companies that devote disciplined, systematic attention from day one move far more efficiently toward opening trials than companies who chose to delay.
August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.
August 4, 2020

The Odd Couple – Part 6: Authoring the Container Stability of Drug Substance and Product Modules

Stability testing is an important part of the drug development and approval process, determining the safety and integrity of the drug and also its shelf life and storage conditions.