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Paper to eCTD Conversion

Why convert to eCTD?

  • eCTD is strongly preferred by FDA/EMA reviewers
  • Publishing is faster and cheaper.  Paper and shipping alone can cost as much.
  • eCTD is already mandatory for the entire EU EMA submission process

Finally, the most important reason, You MUST!

  • When the eCTD mandate goes into effect everyone, even those sponsors with approved application, must convert to eCTD

 

With Aquila’s assistance this process can be quick, easy and will leave you wondering why you didn’t convert earlier.  Check out our free training: Paper to eCTD Conversion

Beyond Direct Conversion, Aquila offers three levels of assistance to sponsors seeking to convert to eCTD:

Direct Conversion

In the US and most other regions conversion is technically achieved by sending in an initial electronic submission.  Once this is done you may never again send a paper submission. Make sure you are prepared.

The recommended process includes:

  1. Send a final paper submission with a Cover Letter indicating that you intend to submit sequences in the eCTD format.
  2. After a few days to a week send your first eCTD sequence with a cover letter and form indicating that you are now sending eCTD formatted submissions.  Aquila recommends using the next available submission number as your initial sequence number

Please note that this is a very risky approach for the simple reason that once you make an eCTD structural decision it is difficult or even impossible to reverse it.  If your prior paper submissions are complex (more than 3-5 small submissions) then it is likely that you will structure your eCTD in a way that is incompatible with existing data and future plans.  This makes the submission extremely difficult and costly to maintain.

Note: Some regions require the initial eCTD sequence be a comprehensive eCTD which represents the current content of your application.  This is equivalent to Aquila’s Comprehensive Conversion.

Other Things to Consider:

  1. Procure or create eCTD templates which will allow you to maintain your eCTD sequence easily.
  2. Set up an FDA ESG account.  These are cheap and relatively simple to create and allow you to control your submissions in-house.

Essential Conversion

Aquila analyzes your existing documents and creates an XML backbone from which future submissions can be built with confidence. This process includes:
     1. Aquila’s Assessment of your application
     2. Developing a life cycle plan for the eCTD application
     3. Creation of a regionally compliant backbone
     4. Training on eCTD management
     5. SME assistance during the first eCTD sequence
A typical timeline for an IND conversion with 20-30 sequences:
     1. Aquila downloads all content (1 day)
     2. Aquila reviews application (1 week)
     3. Meeting with sponsor to discuss findings and lifecycle plan (1 day)
     4. Create ICH and regional backbones (1 week)
     5. Deliver backbones and train sponsor (1 day)
     Total time: ~3 weeks from kickoff

Basic Conversion

Aquila provides a compliant backbone and then determines the current version and correct location for all content. There will be no guessing when you create submissions. This level is our most popular and provides the greatest return. The process includes:
     1. Everything in the Essential Conversion
     2. A detailed review of the current application status
     3. Identification of all “current” content
     4. Placing copies of all current content in the appropriate eCTD location
     5. Develop a Trace matrix to track the content source.
A typical timeline for an IND conversion with 20-30 sequences:
     1. Aquila downloads all content (1 day)
     2. Aquila reviews application (1 week)
     3. Meeting with sponsor to discuss findings and lifecycle plan (1 day)
     4. Create ICH and regional backbones (1 week)
     5. Identify the current content. (1 week)
     6. Transfer current content to the eCTD and create the trace matrix. (1 week)
     7. Provide basic conversion to sponsor and provide eCTD training. (1 day)
     Total time: ~5 weeks from kickoff

Comprehensive Conversion

It is always best to begin an application as an eCTD and a comprehensive conversion provides exactly this. Aquila will create a complete eCTD application that will allow you to convert to eCTD without any legacy difficulties. This process includes:
     1. Everything in the Basic Conversion
     2. A copy of eCTD Accelerator – Templates if you do not already have a preferred template set
     3. Transfer of all content to the eCTD Template system.
A typical timeline for an IND conversion with 20-30 sequences (Assuming mostly rendered text):
     1. Aquila downloads all content (1 day)
     2. Aquila reviews application (1 week)
     3. Meeting with sponsor to discuss findings and lifecycle plan (1 day)
     4. Create ICH and regional backbones (1 week)
     5. Identify the current content. (1 week)
     6. Transfer only current content to the eCTD templates and create trace matrix. (3 week)
     7. Provide comprehensive conversion to sponsor and provide eCTD training. (1 day)
     Total time: ~8 weeks from kickoff
Note: This does not include bookmarking and linking remediation since it is unnecessary for an internal sequence. Remediation can be provided should the sponsor require it.

 

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