As an end manufacturer, of course a PMTA market authorization is important for you. As part of the review process, you may have received a deficiency letter from FDA. But what does this mean? This means that FDA determinded your application was worthy of an in-depth scientific review and during that review they have identified gaps in your data. now you will have to design appropriate studies generate that data interpret and compile it and then submit it to FDA and you will only have 90 days to do this. So what's the solution?

At BNS, we create tailor-made solutions for our clients to help them address their deficiency letters. We share your sense of urgency and are dedicated to supporting your application with robust APPH evidence. We will help you address your deficiency with accuracy confidence and control. let's go on a journey together to bridge the gaps and keep your products safe on the market. Contact us today for a PMTA deficiency letter and consultation.