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Submissions Consulting

Electronic Submissions like eCTD can greatly speed the publishing process and ease your review.  However, if the lifecycle is not carefully planned and managed, eCTD can also lead to very difficult maintenance, added man-hours for rework, filing difficulties even to the point of RTF and a general reduction in the financial value of the product.

Lifecycle Planning

Aquila can help you map out potential lifecycle issues prior to publishing. This will reduce the work necessary for the initial publishing as well as the long term lifecycle maintenance.  By carefully mapping out the anticipated lifecycle you can more easily expand into new markets or develop new formulations and indications.

eCTD Backbone Planning

In addition to long term submission planning, Aquila can also assist you to develop the eCTD backbone for your submission. This will reduce the potential technical errors in your eCTD application. We can assist in:

  • Identifying the correct granularity
  • The correct location for non-clinical and clinical studies
  • Legacy vs. E3 compliant studies
  • Necessary clinical data packages
  • Naming / format conventions

Technical Assessment

Aquila can provide detailed technical assessments of existing applications. When purchasing new products, it is important to verify that all sequences are complete and to identify any inconsistencies. Without this information it becomes difficult to predict how difficult it will be to maintain the application. This can significantly affect the man-power necessary to support a new product. Should you wish to sell a product, having a clean and clear application will assist with the sale by aiding transparency and the ease of review for potential buyers.

Paper Conversion

Converting traditional paper applications to eCTD can result in a significant cost reduction. The eCTD format allows for easy identification of current documents and allows for easy updating of specific sections in a very standardized format. However, simply submitting new sequences in eCTD rather than paper will result in significant rework as older submissions are referenced. Aquila can prepare your application to allow for easy updating in eCTD. This will save you significant time as you maintain your product.

What Clients Say

"I was surprised to discover that an initial application takes up to 2,000 man-hours to publish but Aquila helped us finalize our application in months instead of a year!" - Director of Regulatory

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