CTD – DSI InPharmatics

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.

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.

August 4, 2020

Published by Meranda Parascandola at August 4, 2020

The Odd Couple – Part 6: Authoring the Stability of Drug Substance and Product Modules

Stability testing is an important part of the drug development and approval process, determining the safety and integrity of the drug and also its shelf life and storage conditions.

August 13, 2020

Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.

September 1, 2020

Published by Meranda Parascandola at September 1, 2020

How to File an Invincible IND Application

Ideally, even before the research phase, you should study the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s web site (and below), and determine how your organization can best meet those requirements. Companies that devote disciplined, systematic attention from day one move far more efficiently toward opening trials than companies who chose to delay.

September 24, 2020

Published by Meranda Parascandola at September 24, 2020

A Storybook Approach for A Successful End of Phase II (EOP2) CMC Meeting

Ideally, even before the research phase, you should study the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s web site (and below), and determine how your organization can best meet those requirements. Companies that devote disciplined, systematic attention from day one move far more efficiently toward opening trials than companies who chose to delay.

September 16, 2021

Published by Meranda Parascandola at 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).

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.