IND – Page 2 – DSI InPharmatics

October 27, 2020

Published by Meranda Parascandola at October 27, 2020

What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission

The FDA’s regulatory requirements for process validation highlights the need for defining Critical Process Parameters (CPPs) based on Critical Quality Attributes (CQAs). As described by the FDA, a CQA is a characteristic within a range that ensures a specified level of product quality. These requirements highlight the focus of QbD, or Quality by Design. The ICH describes this view of quality assurance that focuses more on validating the process through control parameters and less on defining quality based on product testing.

December 15, 2020

Published by Meranda Parascandola at December 15, 2020

Phase 1 Stability; Agency Expectations

Before you decide how much stability data you require, it is vital to understand the nature of your Dosage Form and Delivery System Requirements (the route of administration and delivery system). Even if there is a diversity of testing in place, these choices have a significant impact on the scientific and regulatory aspects of a stability protocol, which can still fail to meet the most stringent regulatory reviews.

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.

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.