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Aquila Solutions

eCTD Regulatory Publishing, Consulting and Strategy

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About Aquila


Aquila Solutions was founded in 2010 with the primary purpose of aiding small to medium pharmaceutical and biologic companies with navigating the regulatory systems. We have successfully published applications for biologics, sterile products, and combination products, among others.


The services that Aquila offers include most forms of eCTD Regulatory Publishing, Regulatory Consulting and Strategy, and Project Management as well as Label Authoring. We pride ourselves on our accuracy, flexibility, and fast turnaround.


In addition to our Publishing and Project Management services, Aquila Solutions is proud to offer editorial revision and minor formatting, as well as technical assessment and verification of existing applications.

Our Top Accomplishments

pages published to the FDA in 2022

Approximate pharma submissions done annually

active applications under management


submissions can be done same day / next day


submissions marked as Refuse to File

News & Events



Do you have any questions?

Applications to the FDA may seem daunting. If you have any concerns about the process or questions about your regulatory journey, feel free to reach out to us! 

Coming soon

eCTD 4.0 is on its way!

What does eCTD 4.0 mean for you?  Reach out to us for more info on being prepared for the change.


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“Our interactions with Aquila over the last three years can be characterized as nothing short of successful on several submissions. This group has consistently gone above and beyond our expectations.”
- CJN, Regulatory Affairs Service Provider

Contact Us

For more information about who we are and what we can do for your submission, please contact us!