November 18, 2021

The Do’s And Don’ts of Selecting A Contract Manufacturer

As any pharmaceutical company knows, most drugs don’t make it into the clinic so the medical chemistry process early on involves just a few kilograms of product. But if all goes well, and the drug makes it into the clinic, suddenly the quantities become metric tons or more, and the manufacturing and safety processes become quite different.
December 2, 2021

Drafting a Marketing Application? Let Your Creativity Bubble Up

The Quality Modules 2 and 3 are well-defined components 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.
May 18, 2022

What is a Quality Management System?

A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.