Comprehensive review of your existing dossier against current Kazakhstan and EAEU requirements.
A customized regulatory roadmap with timelines, risk mitigation, and resource allocation.
Expert preparation and submission of complete registration packages to the relevant authorities.
Active follow-up, query management, and ongoing post-approval lifecycle maintenance.
Every project follows a rigorous 4-stage audit, strategy, submission, and maintenance workflow.
Audit of Module 1-5 CTD documents, identifying missing bioequivalence or stability data, and establishing authority fee budgets.
Selecting Reference State vs Concerned States under EAEU rules, translating artwork into Kazakh/Russian, and scheduling testing samples.
Submitting through electronic portals, liaising with expert committees, and submitting prompt response packages to official queries.
Obtaining Marketing Authorization Certificates, establishing local PV surveillance, and managing post-approval amendments.
Let our regulatory experts guide your product through every step of the registration and compliance process. Reach out today for a no-obligation consultation.
