Introduction The U.S. Food and Drug Administration (FDA) is facing a significant shake-up with a recent workforce reduction of approximately 3,500 positions as part of…
In the biopharma industry, regulatory compliance and meticulous documentation are the bedrock of success. Especially as it relates to Chemistry Manufacturing and Controls (CMC). Small…
Introduction The U.S. pharmaceutical landscape is undergoing a transformative shift with the FDA’s “FDA PreCheck” proposal, launched under Executive Order 14293 to bolster domestic manufacturing…
Windshire Group is proud to have been featured in Season 1, Episode 6 of Court Square Group’s podcast, Driving the Business of Science, titled “The…
In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…
Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements…
Last year’s guidance from the FDA regarding human gene therapy products (Human Gene Therapy Products: Incorporating Human Genome Editing Guidance for Industry, FDA January 2024)…
Human Gene Therapy Products: Incorporating Human Genome Editing Guidance for Industry: Part 1 The FDA recently released guidance (FDA- Human Gene Therapy Products: Incorporating Human…
CPV is a method used in pharmaceutical manufacturing to ensure consistent product quality and regulatory compliance. It involves the continuous monitoring of critical process parameters…
CMC Due Diligence Best Practices Due diligence is crucial in the pharmaceutical industry for mitigating risks and ensuring success, especially during mergers, acquisitions, and licensing…