Project Management

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.
May 4, 2022

Project Management: A Complex Necessity

Many pharma and biotech startups may question the idea of whether a Project Manager is really useful; is it simply another layer to add to the complex array of personnel and job responsibilities? There are a number of tools available; most commonly recognized among these is the classic Gantt chart – so why add another person to the mix just to manage that?