Business Case eSubmission NDA

Business Case eSubmission NDA:

The client had a very tight submission calendar and requested support from Asphalion for the eCTD publishing and submission activities.

It is worth mentioning that the day before the NDA submission, the client was sending additional comments and amendments.

SOLUTION:

Full outsourcing of the eCTD publishing activities and supporting the client throughout the whole NDA application process.

The following activities were performed:

• Kick-off Meeting (KoM) to define publishing plan and calendar
• Document formatting and preparation
• Specific assistance with complex datasets the client did not have any experience with
• eCTD publishing and submission using the US gateway

OUTCOME:

It is worth highlighting that the ordinary submission timeline for an initial NDA application usually takes about a month. In this occasion, however, due to the tight submission calendar Asphalion performed the activities and submitted the NDA within two and a half weeks.

Asphalion is currently providing continuous support with the responses to Information Request sequences during the evaluation process, which also have very tight deadlines.