Driving the Business of Science: The Importance of Quality
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…
New Draft Guidance on the Use of Artificial Intelligence in Regulatory Decision-Making for Drug and Biological Products
In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…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): Beyond Mere Compliance
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…
Chemistry Manufacturing and Controls in Human Gene Therapy Products: FDA Guidance Part 2
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
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…
January 2025 | Implementing Continued Process Verification (CPV): Smart Business and a Regulatory Expectation
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…
December 2024
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…
November 2024
CMC Due Diligence Common Stumbling Blocks Conducting thorough CMC due diligence in the pharmaceutical industry is essential to avoid pitfalls that can jeopardize the success of…
September 2024 | Avoiding Pitfalls in CMC: The Power of ‘Measure Twice, Cut Once
Running afoul of the adage, “measure twice, cut once” can upend a construction project. But what it can do to a CMC (Chemistry, Manufacturing, and…
August 2024
In this fast paced and dynamic life sciences industry, it’s worth remembering regulatory compliance is a journey, not a destination. It requires a proactive approach to adapt…