The Joys of CDMOs
April 25, 11am EST
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"The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.”…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
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…
See Our Recorded Webinar Below May 4, 11am EST
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…
Dr. Blackwell, Founder and Principal Consultant at The Windshire Group, comments on learnings for process development as a result of meeting pandemic challenges. There are…