solutions

Regulatory Affairs

We design and execute right-sized regulatory approaches that match your stage, capital position, and risk profile while positioning you for investor confidence and positive submission results with strong relationships with the FDA. 

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 can execute the strategy, end-to-end submissions and ongoing relationship management, supporting your go-to-market goals. 


#1 


Strategy & Alignment

  • Regulatory pathway strategy 
  • Pre-Submission planning & FDA interaction strategy
  • Regulatory & clinical endpoint planning & alignment 
  • Breakthrough Device strategy 
  • Global expansion planning 

#2 


Submission & Execution

  • 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

#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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