Insightful Thought Leadership
New FDA Draft Guidance on ICH Q3E: What Steps are Needed to Master the Risk-Based Framework for Extractables and Leachables Control? ICH Q3E represents a…
What Are the Best Practices for Bio/Pharma CMC Regulatory Compliance? A Proactive Guide to Documentation and Digital Strategy In the highly scrutinized bio/pharma industry, regulatory…
In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…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…