Regulatory – DSI InPharmatics

November 4, 2021

Published by Meranda Parascandola at November 4, 2021

How To Tell A Compelling CMC Story In Your NDA/BLA Application

Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.

November 18, 2021

Published by Meranda Parascandola at November 18, 2021

The Do’s And Don’ts of Selecting A Contract Manufacturer

As any pharmaceutical company knows, most drugs don’t make it into the clinic so the medical chemistry process early on involves just a few kilograms of product. But if all goes well, and the drug makes it into the clinic, suddenly the quantities become metric tons or more, and the manufacturing and safety processes become quite different.

March 2, 2022

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

Published by Meranda Parascandola at March 2, 2022

When Decisions Decide the Outcome

Beginning with spring training through the dog days of summer to the stretch drive, every decision on and off the field can affect the postseason outcome.

February 10, 2023

Published by Meranda Parascandola at February 10, 2023

A New Chapter in Clinical Trials: The Mandatory CTIS and Its Impact – Insights by Randall Lis

Navigating the New Frontier of Clinical Trials! Randall Lis shares expert insights on the mandatory CTIS implementation, revolutionizing the EU clinical research landscape. Explore the key trends, benefits, and challenges shaping this transformative journey

December 12, 2023

Published by Meranda Parascandola at December 12, 2023

Quality Resolutions

There are no holidays or time off when it comes to complying with regulations. Companies always need to be ready to meet the latest standards. With that in mind, new FDA programs are sure to keep pharmaceutical companies of all sizes busy in the year ahead. Here’s how to get through.