Regulatory Affairs

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?

January 6, 2023

Published by Meranda Parascandola at January 6, 2023

Your Company’s FDA Meeting Survival Guide

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.