Strategy

April 16, 2019
HOW A FALLING APPLE INSPIRED THE UNDERSTANDING OF GRAVITATIONAL FORCE

How a Falling Apple Inspired the Understanding of Gravitational Force

The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.
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 SlumpGetting 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.
January 21, 2021

Understanding Regulatory Submissions and the Role of Regulatory CMC Project Management

What is regulatory CMC? An individual in a regulatory affairs CMC role provides the strategy and knowledge needed to ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies, such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). CMC regulatory is pivotal in ensuring that drugs and treatments being manufactured are safe, effective, and of high quality for patients.
February 11, 2021
Year of the Ox

Will the Year of the Ox Bring You Luck?

What daring goals did you set in 2020?  Did you reach them? 2021 is a New Year. Your year to get clear on where you're going and how to get there.