Regulatory Affairs

February 14, 2019

Your FDA Meeting Survival Guide Has Arrived

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
May 22, 2019

Helping Our Best Clients Accept A Healthy Level of Regulatory CMC Risk (Ed or Op-ed?)

Some individuals have an off-kilter sense of risk. They may play it overly safe and refuse to make even the most prudent bets on their development program. Or they may gamble willy-nilly, putting all their chips on wildly unpredictable long shot CMC strategies and preceding advice.
May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.
July 31, 2019

CMC Regulatory Is the Ringo Starr of Regulatory Affairs

Always present, rarely seen, and increasingly essential, the fast-growing area of Chemistry, Manufacturing and Controls (CMC) of pharmaceutical products is slowly emerging as a titan in its own right.
August 21, 2019

Key Elements of a CMC Strategic Development Plan

How to Avoid the End-of-Summer Slump Getting your productivity back on track requires using your energy wisely, whether it's stockpiled from vacation or running on fumes. Here are a few ways to turn the end of summer into a springboard for a productive Autumn.
September 19, 2019

What Would Bruce Lee Do?

How would Bruce Lee develop a viable and effective chemistry, manufacturing and controls (CMC) regulatory strategy while focusing on ensuring a viable and effective clinical development strategy to keep the product moving forward, when the odds of clinical success were against him?