Insightful Thought Leadership
In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…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…
The ten key steps to manage and mitigate risk within life science companies By: Erin O'Brien Managing and mitigating risks with a structured plan is…
By James Blackwell, President, Windshire Group, LLC and Labshire, LLC May 12, 2024 Download the PDF of this blog! CMC Due Diligence | May 2024…
The news of the Novo Nordisk (Novo Holdings) intent to acquire Catalent has taken the industry by storm. It is unprecedented and shifts the risk…
Sooner or later, every biotech, pharma or medical device company will face an audit. Use this general checklist to evaluate your organization and take proactive…
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing your company’s overall development strategy for a medicinal product is…
Risk Framing and Conflict Mitigation Strategies in the Ukrainian Crisis The Windshire Group’s clients are facing unprecedented challenges to their supply chains from pandemics to…