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Bio-Pharma

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.

Biologics and Pharmaceuticals:

Working With Clients to Speed Up Submissions

Aquila offers the following services:

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eCTD Publishing & Consultation

  • Working with clients, Aquila helps to plan and manage the lifecycle and XML backbone to guide a variety of eCTD submissions, including INDs, NDAs, (A)NDAs, DMFs, BLAs, and MAAs.
  • Aquila’s in-house publishing staff handles all publishing and processing activities to prepare your application for submission to FDA.
  • Our team can prepare most submissions with a same-day or next-day turnaround.
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SPL Authoring

  • Aquila’s publishing staff includes a specialized labeling team, allowing the production and validation of FDA-compliant labels, such as over-the-counter drug labels, in a matter of hours.
Aquila Solutions eCTD

eCTD Structure

Get In Touch

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Other Services

  • Aquila allows clients to be confident in their new product purchases by offering a full technical assessment of any existing applications. When purchasing new products, it is important to verify that all sequences have been completed and to identify any inconsistencies or errors.
  • Aquila has encountered some submissions with unsatisfactory formatting and editing. Documents with mislabeled sections, tables without titles, and other similar errors can occur while translating data into documents. Aquila offers full document revision, tracking all changes so the client can make the final decision on all revisions.
Aquila Solutions eCTD

eCTD Structure

For more information about who we are and what we can do for your submission, please contact us!