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…
The ten key steps to manage and mitigate risk within life science companies
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…
The Importance of CMC Due Diligence
By James Blackwell, President, Windshire Group, LLC and Labshire, LLC May 12, 2024 Download the PDF of this blog! CMC Due Diligence | May 2024…
Acquisition Rocks CMO Supply Chain Landscape
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…
Audit Readiness Checklist
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…
Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
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…
Strategies to Re-risk Supply Chains- A Geo-political Crisis Case Study
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…
The Pandemic Caused Process Changes and Lessons for the Future
Dr. James Blackwell, Ph.D, M.B.A discusses how the COVID-19 pandemic has caused significant changes, both disruptions and accelerated development. Lessons learned can inform practices from the…