FDA Regulatory Strategy

Regulatory Strategy

Hack & Associates develops robust regulatory strategies for companies in any stage of the product life cycle.  We use our expertise to create regulatory schemes that will minimize time to market while ensuring full compliance with the FDA.  Pipeline development, clinical trial design, and product labeling are all part of the planning necessary for a successful product launch.  We also evaluate post-market factors such as reimbursement, the market landscape, post-approval data collection, and marketing and production scale-up. 

We can audit clients to find hidden efficiencies and value to their regulatory portfolios.

We help clients avoid the pitfalls associated with complex device development, avoid jurisdictional issues with combination devices, and avoid unnecessary clinical data collection and effort duplication.