In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…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…
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…
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…
Becoming FDA registered and achieving ISO 22716:2007 certification
"The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.”…
See Our Recorded Webinar Below June 28, 11am EST