Regulatory Affairs

May 22, 2019

Published by Meranda Parascandola at May 22, 2019

Helping Clients Accept A Healthy Level of Regulatory CMC Risk

Some individuals have an off-kilter sense of risk. They may play it overly safe and refuse to make even the most prudent bets on their development program. Or they may gamble willy-nilly, putting all their chips on wildly unpredictable long shot CMC strategies and preceding advice.

May 30, 2019

Published by Meranda Parascandola at May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.

July 31, 2019

Published by Meranda Parascandola at July 31, 2019

CMC Regulatory Is the Ringo Starr of Regulatory Affairs

Always present, rarely seen, and increasingly essential, the fast-growing area of Chemistry, Manufacturing and Controls (CMC) of pharmaceutical products is slowly emerging as a titan in its own right.

August 21, 2019

Published by Meranda Parascandola at August 21, 2019

Key Elements of a CMC Strategic Development Plan

How to Avoid the End-of-Summer SlumpGetting your productivity back on track requires using your energy wisely, whether it's stockpiled from vacation or running on fumes. Here are a few ways to turn the end of summer into a springboard for a productive Autumn.

September 19, 2019

Published by Meranda Parascandola at September 19, 2019

What Would Bruce Lee Do?

How would Bruce Lee develop a viable and effective chemistry, manufacturing and controls (CMC) regulatory strategy while focusing on ensuring a viable and effective clinical development strategy to keep the product moving forward, when the odds of clinical success were against him?

October 2, 2019

Published by Meranda Parascandola at October 2, 2019

Hey Google, tell me about the importance of living Development Reports

Ready to help, wherever you are! Google's version of Amazon's Alexa, Apple's Siri and Microsoft's Cortana is Google Assistant. It has made incredible progress since its 2016 launch and is probably the most advanced and dynamic of the assistants out there.

October 17, 2019

Published by Meranda Parascandola at October 17, 2019

Developing a Phase-Appropriate CMC Matrix

The landscape of chemistry, manufacturing, and controls (CMC) has continued to shift over time. Just a few decades ago, most drugs were developed from beginning to end by large pharma with well-defined systems of control. Today, this has significantly changed; much if not most early development (Pre-IND to Phase II) work is performed by small- to medium-size emerging biotech sponsors, many of which are virtual companies.

October 29, 2019

Published by Meranda Parascandola at October 29, 2019

CMC and Regulatory Affairs – See the forest and the trees

Here’s the problem: drug development managers must translate guidance into clear program objectives, identifying the data and information that needs to be produced, and prioritize resources and expenditures.

December 3, 2019

Published by Meranda Parascandola at December 3, 2019

Phase 2 to Early Phase 3 Regulatory Opportunities: Return on Investment

To ensure scientific and commercial success, it is critical to understand the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan. Although the primary purpose of a well-designed regulatory strategy is to assure an efficient process for providing new, high quality and effective drugs for patients, it is also essential to effectively maximize the return on investment. Each step along the path to commercialization is important and an effective chemistry, manufacturing and controls (CMC) strategy and ensuing communication plan plays an integral role in the overall success of a product.

February 28, 2020

Published by Meranda Parascandola at February 28, 2020

Why Your Program Needs a Biologics CMC Consultant

Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay?

May 21, 2020

Published by Meranda Parascandola at May 21, 2020

Constructing the CTD Module 3: A Primer…

Module 3 is a well defined component 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.

June 2, 2020

Published by Meranda Parascandola at June 2, 2020

Quality Overall Summary Reviewers Guide

The value of the QOS should be to point reviewers at the most important information to support the quality of the drug in the most transparent presentation possible.