CPV is a method used in pharmaceutical manufacturing to ensure consistent product quality and regulatory compliance. It involves the continuous monitoring of critical process parameters…
CMC Due Diligence Best Practices Due diligence is crucial in the pharmaceutical industry for mitigating risks and ensuring success, especially during mergers, acquisitions, and licensing…
CMC Due Diligence Common Stumbling Blocks Conducting thorough CMC due diligence in the pharmaceutical industry is essential to avoid pitfalls that can jeopardize the success of…
Running afoul of the adage, “measure twice, cut once” can upend a construction project. But what it can do to a CMC (Chemistry, Manufacturing, and…
In this fast paced and dynamic life sciences industry, it’s worth remembering regulatory compliance is a journey, not a destination. It requires a proactive approach to adapt…
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"The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.”…