Aquila Solutions
eCTD Regulatory Publishing, Consulting and Strategy
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.
EDITING AND ASSESSMENTS
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
Approximate pharma submissions done annually
%
submissions can be done same day / next day
%
submissions marked as Refuse to File
News & Events
NOW
2023
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.
Testimonials
