Our Services
Expert Regulatory support for Product Registration in Myanmar
Our Services
We have product registration’s dossier evaluation service and Dossier filling service to help our client to the road of success registration without any pending due to not complies with local requirement.
Consultation service only:
Provide and explain local Registration regulatory information, Regulation Update, Products registration/submission guideline, process and timeline as Per our client request.
Dossier Evaluation service only:
We have product registration’s dossier evaluation service to help our client to the road of success registration without any pending due to not complies with local requirement.
Complete Consultation and Documentation service:
1. Provide consultation service.
2. Advice and guide how to prepare/convert the dossier to meet local requirements
3. Guideline (ACTD guideline) for successful registration fast and effective.
4. Help to evaluate the dossier before submission in order to avoid any pending at MOH.
5. Helps to evaluate Labeling and Artworks
6. Receive dossier with complied requirement from client.
7. Prepare application and submission follow each step of the process flow
8. Keep updating the process to our client
9. Getting the License
Types of Registration Services:
1. Support Pharmaceutical Drug (OTC & Rx) New and Renewal registration
2. Support Medical Device registration
3. Support Food and Health Supplement registration
4. Support Biotech product such as vaccine registration
5. Support Cosmetic registration
6. Support Product Variation Change
Our Company not responsible for the products that:
Failed Lab test at National Health Quality Control due to the products quality that doesn’t meet National Health Quality Control’s standard.
Application rejection or fail on any process of registration due to false document, counterfeit/low quality product or any kinds of conflict that beyond our responsibilities.
