Accelerated Solutions for Your Regulatory Review
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.
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.
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
submissions can be done same day / next day
submissions marked as Refuse to File
News & Events
The Altair eCTD viewer has entered beta testing! Contact us for more information.
Aquila to attend and exhibit at DIA 2021
Aquila has about one dozen accepted PMTAs by CTP as of the initial deadline
Aquila has retained the services of Robert “Buddy” Abercrombie for Business Development