scope

Entering Kazakhstan through the EAEU procedure is not simply a matter of document submission. It means working with a regulatory authority the client has never dealt with, under rules they have not previously worked within. Any error in the dossier at this stage leads to additional months of assessment and a frozen budget.

To complete the first registration under the EAEU mutual recognition procedure for a portfolio of 7 products. To pass the assessment without rejection and avoid losing time to deficiencies that could have been prevented.

entrypoint provided full regulatory support, from dossier readiness assessment through to receipt of assessment conclusions. Prior to submission, the documentation was reviewed for compliance with regulatory authority requirements. The team explained the rationale behind every step. For the client, this was their first experience of the EAEU mutual recognition procedure in Kazakhstan, and no question went unanswered, including general regulatory queries not directly related to the products.

All submitted products passed the assessment with positive conclusions. The client invited entrypoint to participate in the next tender.