Blog

January 21, 2021
blog - Understanding Regulatory Submissions and the Role of Regulatory CMC Project Management (1)

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.
January 5, 2021
blog_ early-stage

Key Strategies for Early-Stage Drug Development

How do you manage product development? What are the decisions and risks associated with it? How can you reduce these risks and get investor support? Design Space InPharmatics Senior Program Management Program Coordinator Judy Magruder shares critical insights on these and other early-stage questions on drug development.
December 15, 2020
Copy of phase 1 stability

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.
December 3, 2020
breakthrough blog

What It Means to Be “Breakthrough”: The Story Behind The FDA Designation

This bill expanded many of the existing governing powers of the FDA but also added one intriguing new provision: the breakthrough therapy (BT) designation, intended to expedite the development and review of drugs for serious or life-threatening conditions.
November 10, 2020
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Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and TIME, can make you or break you) it can be harder to bounce back.
October 27, 2020
control blog

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.