eCTD Services

A-consult can provide eCTD services to enhance your submissions. We have a dedicated team that specialises in eCTD services that can help transform paper based submissions into fully compliant submissions. Our submissions team can transform your legacy data for eSubmission. We can also provide support in the compilation of your eSubmission. The eCTD services team at A-consult have the knowledge and technology to meet your needs.

Making sure that your submissions meet the latest agency requirements is an important factor when creating eCTD submissions. A-consult’s eCTD software contains all the latest agency specifications. Creating compliant and reliable submissions will be a rapid and simple process when using our software.

Further to this, A-consult also provides the following eCTD services:

• eCTD XML backbone validation services
• eCTD and regional guidance consultation
• PDF Bookmarking / Hyperlinking
• eCTD compilation
• Evaluation of promotional materials

When A-consult receives your data and documents the output is subject to the clients requirements. The output can range from eCTD compliant documents to the finalised electronic submission.

By employing cutting edge software, A-consult can provide a quality service to our customers. We provide the same commitment to all of our clients whether they require a small variation or a large MAA.

A-consult also provides clients with on site staff to help clients in the various stages of the eSubmission process. This service is superb for large submissions where additional staff is needed for very specific jobs such as linking or bookmarking.

For more information or to discuss eCTD services please contact us directly.