Bio International Convention
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"The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.”…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…
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…
How to Leverage the Digital Revolution in Early-Stage Companies from The Windshire Group and Court Square Group: Ask The Experts Series
See Our Recorded Webinar Below May 4, 11am EST
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…