We offer a 360 service project-based regulatory and legal strategy and submissions to accomplish your objectives in navigating the regulatory landscape for stem cell and regenerative medicine in The Bahamas.
- You are a global enterprise with an interest operating in The Bahamas. You also want to operate in other international jurisdictions. You need strategic and legal guidance that helps you connect the dots between where you are now, where you are going, and where you want to be in future. We are uniquely qualified to help navigate the complexity of ensuring the success of your brand.
- You need to get through The Bahamas National Stem Cell Ethics Committee (NSCEC) regulatory process. You also need to ensure that you are able to obtain regulatory approval from FDA and other regulatory authorities (such as EMA) in future. We have one-of-a-kind expertise in this area.
- You need to be compliant in clinical trials, as well as safety and efficacy monitoring and evaluations. Failure to do so will be enormously expensive and time consuming not to mention the impact on your competitive edge. We offer a full range of compliance and quality management services to ensure your success.
- You may need to appoint a CRO or outsource certain aspects of the regulatory affairs requirements. We can help you find the right people to get it right the first time.
- You want to maintain your competitive edge. For this you will need to incubate and test new products and services. The HEALinc Health Innovation incubator is designed to help you test and refine the ‘Future-Health’ innovations you want to develop.