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Aquila Solutions 

Accelerated Solutions for Your Regulatory Review

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About Aquila

Purpose

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.

SERVICES

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.

PMTA LEADERS

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 2020

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

04

Jan 2021

Orphan Drugs

The FDA has provided clarity on developing new orphan drugs for the Age of Individualized Medicine.

01

Jan 2021

New Year

Happy New Year! Is a new IND or other drug product in your New Year’s Resolution? Contact us!

30

Sept 2020

Beta Testing

eCTD viewer “Altair” has entered beta testing! Contact us for more information.

16

Sept 2020

Conference

Aquila to attend and present at DIA 2021

Testimonials

Aquila Solutions logo
“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!