Service
Registration of Medicines, Reagents & Equipment in Central Asia
One region, two rulebooks: EAEU procedures in Kazakhstan and Kyrgyzstan, national pathways elsewhere — we work with both daily.
Overview
Registration strategy in Central Asia starts with a fork: Kazakhstan and Kyrgyzstan register medicines under EAEU rules — with a choice of reference state and a mutual-recognition procedure — while Uzbekistan, Turkmenistan and Tajikistan keep national procedures with their own dossier formats, testing and timelines. Choosing the pathway, the sequence and the reference market is where months are won or lost, and it is the first decision we take with you.
The scope goes beyond medicines. Medical devices and laboratory reagents and reactants follow their own regulatory tracks in every market, with separate expertise procedures, safety testing and registration certificates. We register all three product classes — pharmaceuticals, in-vitro diagnostics and reagents, and medical equipment — adapting CTD and technical files to each authority’s expectations, preparing normative documents and certified translations, arranging sample shipments, and supporting GMP inspections of your manufacturing sites.
Approval is the start of the lifecycle, not the end of the project. We maintain registrations through variations and renewals, run local pharmacovigilance systems with an authorized person in each market, and file periodic safety update reports on schedule — so your registration certificate never becomes the reason a tender is lost.
What we deliver
Pathway strategy
Pathway, reference-state and sequencing decisions that shorten total time to market.
Medicine registration
CTD restructuring, normative documents and certified translations for each authority.
Reagents & equipment
Technical files, safety testing and certificates for laboratory reagents, IVD and medical devices.
GMP inspection support
Preparation and on-site support for inspections of your sites by EAEU and national inspectorates.
Expert-query defence
Structured, on-time responses to expertise queries, drafted in the authority’s own logic.
Lifecycle & pharmacovigilance
Variations, renewals, local PV systems and periodic safety reports in every market.
How we work
Four stages, one accountable sequence — from first assessment to steady operations.
- Step 1
Gap assessment
We audit your dossier against each target authority’s requirements and return a gap report with a filing plan.
- Step 2
Dossier build
Modules are adapted, translated and completed; samples, standards and inspection logistics are arranged in parallel.
- Step 3
Submission & defence
We file, track every expertise stage and answer every query until the registration certificate is issued.
- Step 4
Lifecycle management
Variations, renewals and pharmacovigilance run on a maintained calendar for the product’s whole life.
- Step 1
Gap assessment
We audit your dossier against each target authority’s requirements and return a gap report with a filing plan.
- Step 2
Dossier build
Modules are adapted, translated and completed; samples, standards and inspection logistics are arranged in parallel.
- Step 3
Submission & defence
We file, track every expertise stage and answer every query until the registration certificate is issued.
- Step 4
Lifecycle management
Variations, renewals and pharmacovigilance run on a maintained calendar for the product’s whole life.
Related services
Discuss this service with our team
Describe your product and target markets. Within days you will have a concrete plan: pathway, timeline and commercial terms.
