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eCTD services

The eCTD team at A-consult has the skills and technology to help you transform your paper based submissions to a fully compliant eSubmission. Whether you need help transforming your legacy data for eSubmission or assistance in compiling your eSubmission our eCTD team is a very capable and efficient option.

When creating eCTD submissions, it is critical to ensure that your submissions meet the latest agency requirements. Our eCTD software includes all of the latest agency specifications. This makes the creation of consistent and compliant eCTD submissions easy and fast.

A-consults eCTD services include, but are not limited to the following:
  • eCTD and regional guidance consultation
  • eCTD XML backbone validation services
  • PDF Bookmarking / Hyperlinking
  • Evaluation of promotional materials
  • eCTD compilation
  • Submission preparation evaluation service
When you provide A-consult with your documents and data, the output will depend on your company's needs. The output can be anything from eCTD ready documents to the final electronic submission.

Using state of the art software, we deliver quality services to our clients. We handle electronic submission with same quality whether it is a large MAA, a small variation or an amendment.

We can also provide you with on-site staff - which can help you in any step of the process of eSubmissions. This is especially excellent for large extensive submissions where an extra set of hands are required or for very specific jobs like bookmarking or linking.
A-consult a/s
Gladsaxevej 3821
DK-2860 Søborg
Denmark

Tel: +45 38330080
Fax: +45 38330280
a-consultata-consult.dk

 
 
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