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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?

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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.