eSubmission Compilation

Our experienced team will assist you with your Operational eCTDs, NeeS, or other electronic submission tasks and help you navigate in the eSubmission guideline jungle, ensuring that your valid submission will be delivered on time to the authorities. We also offer to support and/or participate in agency meetings and discussions regarding your eCTD.

Submissions can be delivered in any format: electronically with XML (eCTD), NeeS, volumised PDF(s), paper or hybrids according to client and relevant health authority requirements.

Our track record demonstrates the ability to understand the unique compliance issues associated with each dossier format, and we always deliver an end product that meets and often exceeds our client's expectations.