Blog | DSInpharmatics

January 21, 2021

Published by Meranda Parascandola at 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 4, 2021

Published by Meranda Parascandola at February 4, 2021

What the Super Bowl Can Teach Us about CMC Strategy

It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success.

February 11, 2021

Published by Meranda Parascandola at February 11, 2021

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.

March 4, 2021

Published by Meranda Parascandola at March 4, 2021

Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

With comprehensive, integrated CMC Regulatory Strategy, emerging sponsors gain greater insight into their Drug Development programs, avoiding bottlenecks and mitigating risks before they lead to mistakes and costly delays. Boost your compliance performance across the complete lifecycle. Ensure consistency and quality in every transaction.

March 18, 2021

Published by Meranda Parascandola at March 18, 2021

Expedited Drug Development and CMC Management

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, provides us with insight on his background with CMC management and the impact that expedited drug development programs have had on the pharma industry. Learn how to break down regulations, breakthrough designations, and the best practices suitable when it comes to these programs.

April 1, 2021

Published by Meranda Parascandola at April 1, 2021

Establishing Regulatory Starting Materials & Understanding the ICH

There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?

Blogs