Objective
To bring an existing portfolio of medicinal products into compliance with EAEU requirements while simultaneously submitting new products for registration in Kazakhstan. Previous partners had declined the project.
Solution
entrypoint accepted the project. Prior to submission, we conducted a pre-submission dossier assessment, identifying inconsistencies that would have resulted in regulatory deficiencies under a standard submission. The client amended the documentation in advance. In parallel, we conducted readability testing of the package leaflets in accordance with EAEU requirements. The team worked across the full portfolio without breaking it into convenient batches, at the pace the client required.
Outcome
17 products in scope: 11 brought into compliance with EAEU requirements, 6 submitted for registration, 2 of which have already received marketing authorisation. The existing portfolio has been maintained in Kazakhstan. The partnership continues: the company now manages 90% of all medicinal product regulatory procedures through entrypoint.
Case №1
We stepped in where others walked away: full portfolio brought into EAEU compliance on schedule.
When the scope is large and the timeline is tight, many consulting firms decline.
For a manufacturer with dozens of products, this means one thing: the portfolio is at risk and there is little time to find a new partner.
For a manufacturer with dozens of products, this means one thing: the portfolio is at risk and there is little time to find a new partner.
Selected Projects
Get a dossier assessment and a step-by-step action plan
Leave your contact details and a brief description of your enquiry. We will follow up within one business day.
+7 700 688 5772
info@entrypoint.kz
info@enrtypoint.kz