{"id":4148,"date":"2026-07-18T04:57:34","date_gmt":"2026-07-18T04:57:34","guid":{"rendered":"https:\/\/mursmedic.com\/?page_id=4148"},"modified":"2026-07-19T16:06:44","modified_gmt":"2026-07-19T16:06:44","slug":"step-02-regulatory-quality-consulting","status":"publish","type":"page","link":"https:\/\/mursmedic.com\/tl\/services\/result\/step-02-regulatory-quality-consulting\/","title":{"rendered":"step 02 Regulatory & Quality Consulting"},"content":{"rendered":"\t\t
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Regulatory & Quality Consulting<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Our Regulatory & Quality Consulting services ensure your products meet local and international standards, guiding you through compliance, certification, and quality assurance processes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Company<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Operating Countries<\/h2>\t\t\t\t<\/div>\n\t\t
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\n Indonesia<\/span>\n \"ID\"\n <\/div>\n\n
\n Malaysia<\/span>\n \"MY\"\n <\/div>\n\n
\n Vietnam<\/span>\n \"VN\"\n <\/div>\n\n
\n Philippines<\/span>\n \"PH\"\n <\/div>\n\n
\n Singapore<\/span>\n \"SG\"\n <\/div>\n\n
\n Thailand<\/span>\n \"TH\"\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Core Services<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory Consulting <\/h6><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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We help you navigate complex regulatory landscapes through expert advice, product registration support, and compliance due diligence to ensure market readiness.<\/div>
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a. Regulatory Advice<\/strong><\/div>
Tailored guidance on local regulations to align your product strategy with compliance requirements.<\/div>
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b. Product Registration<\/strong><\/div>
End-to-end support in securing product license across Southeast Asia’s healthcare markets.<\/div>
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c. Due Diligence<\/strong><\/div>
Thorough regulatory checks before market entry to identify and mitigate compliance risks.<\/div>
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1. Product Registration\u200b<\/div>
2. Product Notification\u200b<\/div>
3. Amendment Submission\u200b<\/div>
4. Assessment Application\u200b<\/div>
5. Cosmetic Notification<\/div>
6. Due Diligence\u200b\u00a0<\/div>
7. Initial Assessment<\/div>
8. Regulatory Advice\u200b\u00a0<\/em><\/div>
9. BAPETEN Certificate Registration<\/div>
10. Dossier Preparation, Review, & Monitoring According to CSDT\u200b<\/div>
11. Product Review and Monitoring<\/div>
12. Product Classification<\/div>
13. Product Information Letter Application<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Product Coverage<\/h5>\t\t\t\t<\/div>\n\t\t\t\t
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    \r\n
  • Medical Device<\/li>\r\n
  • Drugs<\/li>\r\n
  • Cosmetics<\/li>\r\n
  • Food<\/li>\r\n
  • Health Supplements<\/li>\r\n
  • Household Health Supplies<\/li>\r\n
  • Household Urban Pesticide<\/li>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t
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    Quality Consulting <\/h6><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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    We strengthen your quality systems through audits, documentation support, and strategic improvements to meet international and local standards.\u00a0<\/p>

    1. QMS Document Creation\u200b<\/div>
    2. PBF Application\u200b<\/div>
    3. CPKB Certification\u200b<\/div>
    4. Halal Certification\u200b<\/div>
    5. Conformity Assurance for Standard Certificate\u200b<\/div>
    6. CDAKB Certification<\/div>
    7. CDOB Certification\u200b<\/div>
    8. CPAKB Certification\u200b<\/div>
    9. IDAK Certification<\/div>
    10. SMKPO Certification\u200b<\/div>
    11. PSB Facilities Inspection<\/div>
    12. SIPA Application<\/div>
    13. CPPOB Certification\u200b\u00a0<\/div>
    14. Assistance of DIP Audit\u200b<\/em><\/div>
    15. CAPA Completion<\/div>
    16.Technical Advice<\/div>
    17. Quality Control<\/div>
    18. NIB Amendment<\/div>
    19. GMP Clearance<\/div>

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    Product Coverage<\/h5>\t\t\t\t<\/div>\n\t\t\t\t
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    • Medical Device<\/li>\r\n
    • Drugs<\/li>\r\n
    • Cosmetics<\/li>\r\n
    • Food<\/li>\r\n
    • Health Supplements<\/li>\r\n
    • Household Health Supplies<\/li>\r\n
    • Household Urban Pesticide<\/li>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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