Blog

December 15, 2021

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.
December 2, 2021

Drafting a Marketing Application? Let Your Creativity Bubble Up

The Quality Modules 2 and 3 are well-defined components of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies.
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.
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.
October 7, 2021

Avoiding and Addressing Surprises in the API Manufacturing Process

When you’re developing and manufacturing your active pharmaceutical ingredients, the last thing you want to deal with is surprises. Unfortunately, even with the soundest methods, processes, and strategies, problems occur in manufacturing.
September 16, 2021

Starting Early: How to Ease the Process of a New Drug Application

Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).