solutions

Regulatory Affairs

We position you for investor confidence and positive submission results through strong relationships with the FDA by designing and executing right-sized regulatory approaches that match your stage, capital position and risk profile

Whether you need a concise regulatory flight plan to support early fundraising or a fully executed strategy for Series A and beyond, we help you chart, navigate and fly a clear, defensible path. With Avio as your co-pilot, we support your go-to-market goals by executing the strategy, end-to-end submissions and ongoing relationship management.

Quality Assurance

#1 


Strategy & Alignment

  • Regulatory pathway strategy 
  • Pre-Submission planning & FDA interaction strategy
  • Regulatory & clinical endpoint planning & alignment 
  • Breakthrough Device strategy 
  • Global expansion planning 
  • End-to-end submissions – Breakthrough, Pre-Submission, 510(k), De Novo, and PMA experienced
  • IDE submissions for significant risk device studies
  • eSTAR and Technical File creation, review, & submission Labeling and IFU development
  • FDA establishment registration and device listing
  • Deficiency letter response

#2 


Submission & Execution

#3 


Post-market growth

  • Letters to file
  • Special 510(k)s
  • Label expansion
  • Audit preparation and representation

Avio has been an amazing force multiplier to my company…guiding us through the process of obtaining FDA Breakthrough Device Designation. I definitely recommend them to other entrepreneurs!” 

Andy Obst

president, Fistula Solution

Want to see what your success could look like?

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