OUR SERVICES Regulatory Registration
Zenith Star provides professional support and coordination for pharmaceutical and food supplement registration projects in Kazakhstan and under applicable EAEU regulatory requirements.
Almaty, Kazakhstan
& 20+ pharma products in CIS countries
Regulatory Registration
Pharmaceutical Registration
Zenith Star has supported the registration of more than 20 pharma products in various CIS countries.
Our pharmaceutical regulatory support may include:
- Initial regulatory pathway assessment
- Registration strategy
- Documentation and dossier coordination
- Regulatory project management
- Coordination with relevant parties
- Registration process support
- Post-registration assistance
Each project is assessed according to the product, manufacturer, existing documentation and applicable regulatory requirements.
Food Supplement Registration
Zenith Star has supported the registration of 40+ food supplement products across a range of dosage forms and categories.
Our experience includes:
- Tablets
- Capsules
- Syrups
- Drops
- Effervescent tablets
- Disintegrating tablets
- Other applicable dosage forms
A structured approach to registration
Product Assessment
Understanding the product, composition, dosage form and existing documentation.
Regulatory Pathway
Identifying the applicable registration pathway and requirements.
Documentation
Reviewing and coordinating the documentation required for the project.
Registration Support
Managing and coordinating the registration process with the relevant parties.
Post-Registration
Supporting the client with appropriate post-registration requirements, where agreed.
Important Disclaimer
Regulatory decisions are made by the relevant competent authorities. Zenith Star provides professional registration support and project coordination and does not guarantee regulatory approval.
Looking to Enter Kazakhstan or the EAEU?
Whether you need regulatory support, a market-entry partner or assistance identifying potential business relationships, Zenith Star would be pleased to discuss your requirements.