Patents and Regulatory Research

One of the biggest challenges facing our clients is navigating the often complex licensing and regulatory requirements preventing their product from reaching the market. With academic acumen and access to relevant publications, miLEAD consultants are well-equipped to assist clients understand the regulatory landscape, intellectual property implications for their business, and other technical aspects of commercialization. Ways that miLEAD has helped past clients navigate these matters are showcased below.

 

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The Client: Start-up Drug Developer

The Project: The client approached miLEAD in need of information for a Phase I pilot grant application. Consultants investigated regulatory requirements and accreditations associated with the client’s specific product and service.

The Deliverable: miLEAD provided an extensive overview of Clinical Laboratory Improvement Amendments (CLIA) certification tailored to the client’s product. We also worked together to form a strategy to initiate this strategy and gave an overview of what the client could expect during the process.