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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 regulatory systems. We have successfully published applications for biologics, sterile products, combination products, and tobacco products.

SERVICES

Aquila’s services include most forms of eCTD and eTTD Regulatory Publishing, Regulatory Consulting and Strategy, Project Management, and Label Authoring. We pride ourselves on our accuracy, flexibility, and fast turnaround, with most submissions doable with same day or next day turnaround.

PMTA LEADERS

Aquila was the first to create PMTA templates for Electronic Tobacco Technical Documents compliant with the regulations put forth by Section 910(b) of the Federal Food, Drug, and Cosmetic Act. These templates have been updated with FDA feedback and guidance.

Our Top Accomplishments

%

Approximate total SKUs submitted to CTP by deadline were Aquila submissions

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

30

Sept 2020

Beta Testing

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

16

Sept 2020

Conference

Aquila to attend and exhibit at DIA 2021

09

Sept 2020

PMTAs

Aquila has about one dozen accepted PMTAs by CTP as of the initial deadline

31

July 2020

Mr. Abercrombie

Aquila has retained the services of Robert “Buddy” Abercrombie for Business Development

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!