Whether you are an inventor, company, or investor, you need to be aware of the probable FDA regulatory status and approval pathway of proposed new products and product concepts. We can guide you through the process, particularly in:
Determining the application or notification type and assisting with supporting data required for FDA concurrence or approval
Drafting meeting requests and preparing for meetings with FDA and expert committees
Assisting with the preparation of requests for determinations for combination products
Resolving complications that may arise during FDA application review
Providing guidance throughout the approval and notification process
Reviewing promotional statements and claims to promote products in the market