Regulatory Submissions & Engagement

Applications

Have a product that is regulated by the FDA?

The Sanova Team can take your product application from start to finish, regardless of the product category -- PMTA, MRTPA, 510k, PMA, NDIN, Facility Registration,  Product Listing.  Our experts can help.

Response Letters

Recieved a deficiency letter or other agency notice and you're not sure what to do? 

Our experts can quickly assess and strategize with you to prepare your response. We pride ourselves on partnering with internal and external teams to ensure the best and most efficient levels of service.

Meetings and Briefing Materials

Preparing for an FDA meeting can be time consuming and require a diverse set of skills and expertise.  But, preparation is critical.

Our team can help you and your team ensure that you have the right materials to make your points and that you're prepared to respond to agency questions and concerns.  We help you put your best foot forward.

Presentations to Advisory Bodies

Have a meeting with an FDA advisory committee?

Whether you have an Advisory Committee (AdComm) meeting or a. Tobacco Products Scientific Advisory Committee (TPSAC) meeting, our team has the broad experience and skills needed to plan and execute a successful strategy.

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