status

scope

In regulatory affairs, what matters is not only what the consultant does. It is also what they do not do, and why.

Objective

A pharmaceutical manufacturer approached entrypoint following a rejection after an EAEU GMP inspection. The previous consultant, who had supported the inspection, had informed the client that approval could be obtained through informal arrangements with the regulatory authority. The client came with a request for post-rejection support and expected a guarantee of outcome.

entrypoint conducted an initial qualification of the request. In the course of the discussion, it became clear that the client was expecting a success-fee payment model and was oriented towards approaches that have no place in regulatory practice.

The entrypoint team stated its position clearly: the Kazakhstani regulatory authority operates within a legal framework, and decisions are made on the basis of documentation and compliance with EAEU requirements. Informal methods are not part of our practice, neither as a tool nor as a promise.

The decision was made to decline the project.

The engagement did not proceed, and that was the right outcome. Taking on a project with demonstrably incorrect expectations would have meant either accepting obligations that could not be fulfilled or working under conditions incompatible with professional ethics. entrypoint supports regulatory procedures in strict accordance with the requirements of the legislation of the Republic of Kazakhstan and the EAEU. This is the only approach that delivers a sustainable result.