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 can assist clients to generally understand the regulatory landscape, intellectual property implications for their business, and other technical aspects of commercialization. An example of how miLEAD has helped a past client navigate these matters is showcased below. Please note that although miLEAD has significant access to relevant publications and resources to guide research regarding regulatory processes and product commercialization, miLEAD strongly suggests consulting a regulatory affairs professional to receive the most accurate recommendations for commercializing products.
project 1
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.
project 2
The Client: Medical Device Start-up
The Project: The client asked miLEAD to perform early-stage regulatory landscape analysis as they considered seeking FDA approval for their product.
The Deliverable: miLEAD provided an overview of the classes of medical devices, how the FDA regulates each class, and the steps to take to begin the medical device approval process. miLEAD also provided the client with information on how to initiate communication with and seek information from the FDA.
