Scope

In regulatory affairs, some deadlines cannot be moved. Missing the submission window means losing the product's regulatory standing and restarting the procedure from the beginning. For a company working with the EAEU for the first time, this represents a double risk: an unfamiliar procedure and no margin for delay.

Objective

To complete the first EAEU submission by a fixed date. With no prior experience of the procedure on the client's side and no flexibility on the timeline.

Solution

entrypoint structured the work around the deadline. Documents were submitted within the first days of receipt, without the intermediate approval steps that extend the process. The team guided the client through every stage of the procedure, answered all questions as the work progressed and maintained full transparency: at every point, the client knew the exact status of their dossier.

Outcome

From project start to submission in 2 months. All 10 products submitted on schedule.
No position missed. Assessment is ongoing.