NDA

January 30, 2020

A Feng Shui CMC Guide to 2020: Will the Year of the Rat bring you Luck?

ncorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both Chemistry Manufacturing and Control (CMC) development and filing approaches range from the minimalist style to a continuously supported style. 
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.