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Regulatory & Quality Consulting

Our Regulatory & Quality Consulting services ensure your products meet local and international standards, guiding you through compliance, certification, and quality assurance processes.

Company

Operating Countries

Indonesia ID
Malaysia MY
Vietnam VN
Philippines PH
Singapore SG
Thailand TH

Core Services

Regulatory Consulting
We help you navigate complex regulatory landscapes through expert advice, product registration support, and compliance due diligence to ensure market readiness.
 
a. Regulatory Advice
Tailored guidance on local regulations to align your product strategy with compliance requirements.
 
b. Product Registration
End-to-end support in securing product license across Southeast Asia’s healthcare markets.
 
c. Due Diligence
Thorough regulatory checks before market entry to identify and mitigate compliance risks.
 
 
1. Product Registration​
2. Product Notification​
3. Amendment Submission​
4. Assessment Application​
5. Cosmetic Notification
6. Due Diligence​ 
7. Initial Assessment
8. Regulatory Advice​ 
9. BAPETEN Certificate Registration
10. Dossier Preparation, Review, & Monitoring According to CSDT​
11. Product Review and Monitoring
12. Product Classification
13. Product Information Letter Application
Product Coverage
  • Medical Device
  • Drugs
  • Cosmetics
  • Food
  • Health Supplements
  • Household Health Supplies
  • Household Urban Pesticide

We strengthen your quality systems through audits, documentation support, and strategic improvements to meet international and local standards. 

1. QMS Document Creation​
2. PBF Application​
3. CPKB Certification​
4. Halal Certification​
5. Conformity Assurance for Standard Certificate​
6. CDAKB Certification
7. CDOB Certification​
8. CPAKB Certification​
9. IDAK Certification
10. SMKPO Certification​
11. PSB Facilities Inspection
12. SIPA Application
13. CPPOB Certification​ 
14. Assistance of DIP Audit​
15. CAPA Completion
16.Technical Advice
17. Quality Control
18. NIB Amendment
19. GMP Clearance

 

Product Coverage
  • Medical Device
  • Drugs
  • Cosmetics
  • Food
  • Health Supplements
  • Household Health Supplies
  • Household Urban Pesticide