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…
Bio International Convention Event
We are thrilled to announce that Windshire's esteemed President and Principal Consultant, Dr. James Blackwell, PhD, MBA/MS, will be attending the highly anticipated Bio International…
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…
Global Cosmetic Company: Analytical Laboratory and Microbiological Testing
Becoming FDA registered and achieving ISO 22716:2007 certification
Whitepaper – Evaluation of Therapeutic Equivalence Guidance for Industry
"The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.”…
Pichia for Bio-Pharmaceutical Manfuacturing-Ask the Experts Webinar Series. Hosted by The Windshire Group, LLC and special guest, Dr. David Blum
See Our Recorded Webinar Below June 28, 11am EST
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…