CTD
October 2, 2019
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
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
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
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
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
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.