Working with clients to speed up submissions.
Aquila Solutions has over 10 years of experience working with biologic and pharmaceutical companies as a consultant and publisher for their submissions to the FDA.
The Consulting Services we offer include, but are not limited to:
Lifecycle Planning and Consultation
Our consulting team can aid clients in planning and managing the lifecycle and submission schedule of their applications from the beginning pre-IND meeting requests to the post marketing requirements of their products.
With our combined 40 years of experience in eCTD Publishing, we have developed a set of templates that can be used to help accelerate your submissions. These guidelines are an excellent starting point for a new submission or a new sequence in a submission! For more information, please visit the Support page.
Sequence Viewer Software
We have developed a proprietary eCTD viewer software, named “Altair,” which gives you a comprehensive overview of your entire submission, sequence by sequence, and has new features in development. For more information, please visit the Support page.
Aquila allows clients to be confident in their new product purchases by offering a full lifecycle assessment of any existing applications. Also, Aquila offers technical assessments and validation of many sponsor software purchases currently on the market.
eCTD Structure from FDA
Sample eCTD Template