Trusted by
18 partner companies, from local manufacturers to global pharma
10 countries. One partner.
Present where you expand
Kazakhstan, Ukraine, Germany, Pakistan, Italy, Egypt, India, Kyrgyzstan, Russia, Belarus
Kazakhstan – Primary entry point
Kazakhstan – Primary entry point
These are the situations we handle every day
Tell us about your project. We'll work through it in 60 minutes
Leave your contact details and a brief description of your enquiry. We'll follow up within one business day.
01
Entering Kazakhstan
or the EAEU for the first time
or the EAEU for the first time
We build the regulatory pathway from the ground up: from dossier assessment to marketing authorisation.
02
Expanding your portfolio or entering new EAEU member states
We manage the full process for each country, end to end.
03
Your dossier was returned with
a list of deficiencies
a list of deficiencies
We analyse the grounds for rejection, assess the risks and develop
a resubmission strategy.
a resubmission strategy.
04
You want to hand regulatory affairs to a reliable partner
Hand them to us. We operate as an external regulatory affairs department: independently, transparently, on schedule.
Our Services
Registration Dossier Audit
We review the documentation before submission, identifying gaps and grounds for rejection while there is still time to address them.
Step by Step
1.
Document Intake
You provide the dossier and supporting documentation.
2.
Expert Review
We assess the dossier, identify gaps
and evaluate the risk of rejection.
and evaluate the risk of rejection.
3.
Report and Recommendations
We deliver a report outlining identified
risks and a remediation plan.
risks and a remediation plan.
4.
Remediation Support
We help address the gaps and prepare
the dossier for submission.
the dossier for submission.
Medicinal Product Registration under EAEU Rules
One agreement for the full cycle, from registration strategy to marketing authorisation in hand.
Step by Step
1.
Registration Strategy
We define the optimal regulatory
pathway for your product.
pathway for your product.
2.
Dossier Preparation
We compile the full documentation package
in accordance with EAEU requirements.
in accordance with EAEU requirements.
3.
Sample Import
End-to-end import support: Ministry of Health permit, document translation and customs clearance.
4.
Dossier Submission
We complete the application, convert to XML format and submit the package to the regulatory authority.
5.
Regulatory Support
We manage the project from submission to decision, responding to all regulatory queries
6.
Marketing Authorisation
We obtain the MA and hand over
the complete document package.
the complete document package.
XML Dossier Preparation
We compile XML dossiers using our proprietary JYLDAM platform.
Regulatory Document Preparation
We prepare the SmPC, package leaflet and quality specification in accordance with EAEU requirements
Step by Step
1.
Document Intake
You provide the documentation
and technical data on the product.
and technical data on the product.
2.
Requirements Review
We compile the document checklist
and request all necessary materials.
and request all necessary materials.
3.
Document Preparation
We prepare the SmPC, package leaflet,
labelling and quality specification.
labelling and quality specification.
4.
Review and Finalisation
We review, incorporate revisions
and prepare the final package for submission.
and prepare the final package for submission.
Package Leaflet Readability Testing
We conduct package leaflet readability testing in compliance with regulatory requirements, in Kazakh and Russian.
Step by Step
1.
Test Protocol Preparation
We review the package leaflet, develop the protocol and questionnaire, and conduct the pilot phase
2.
Testing
Two rounds of 10 respondents, with analysis and revisions after each round.
3.
Report Preparation
We compile the final report and submit
it to you and to the regulatory authority.
it to you and to the regulatory authority.
1
Registration Dossier Audit
We assess the dossier and identify risks before the procedure begins.
2
Regulatory Strategy
We define the optimal registration pathway for the product and territory.
3
Dossier Preparation
We compile the full documentation package in accordance with regulatory authority and EAEU requirements.
4
Submission and Support
We submit the application and manage the project through to the final regulatory decision.
5
Marketing Authorisation
We obtain the MA and hand over the complete document package.
Selected Projects
50
+
Applications submitted under EAEU procedures
3
+
Years in practice
18
+
Partner companies
10
+
Countries covered
Our Mission
To serve as the bridge between science and the patient, ensuring the right products reach the people who need them. Through precision, care and accountability, we advance holistic health.
Our Vision
entrypoint is where your product's regulatory journey begins, in Kazakhstan and across the EAEU. The name is intentional: in software, a program cannot run without a defined starting point. In regulatory affairs, we are that point.
Why entrypoint
Predictability
You see every step and know what comes next. Dossier status, timelines and risks: all visible.
Direct Access
to Expertise
to Expertise
We answer every question on the product, the procedure or the regulator's reasoning. You always know who to turn to.
Speed Without Compromise
We work without delays: submission within the first days of receiving the documentation.
Inside Knowledge
Our experts have worked within EAEU regulatory authorities. We understand the process from both sides.
Proactive
by Default
by Default
We identify weaknesses before they become grounds for rejection.
We Take
Ownership
Ownership
If something goes wrong, we address it and resolve it. We do not leave you to handle it alone.
Technology
Built from Practice
Built from Practice
Kazakhstan • EAEU
JYLDAM
The first web-based platform in Kazakhstan for compiling registration dossiers in XML format in accordance with EAEU requirements. Developed on the basis of real regulatory practice.
Our Working Standard
entrypoint + JYLDAM
For dossier compilation under EAEU requirements, we use our proprietary JYLDAM platform.
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