Introduction The U.S. pharmaceutical landscape is undergoing a transformative shift with the FDA’s “FDA PreCheck” proposal, launched under Executive Order 14293 to bolster domestic manufacturing…
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…
The Windshire Group, LLC will be attending DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum. February 14-16, 2022 in North Bethesda, MD. They will…
Improving the understanding of your existing or future needs (from the proposed CapEx, capacity expansion, etc.) is useful way to plan this critical activity. Also,…