Regulatory Excellence
for Life Sciences
Medbiosolution provides strategic regulatory consulting services for pharmaceuticals, medical devices, food supplements, cosmetics, and healthcare products across Thailand and ASEAN.
We support clients throughout the product lifecycle—from regulatory strategy and product registration to post-approval compliance and market entry.
REGULATORY &
REGISTRATION SERVICES
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Pharmaceutical Registration
Comprehensive regulatory support for pharmaceutical product registration in compliance
with Thai FDA, ASEAN Common Technical Dossier (ACTD), and applicable ICH guidelines.
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Medical Device Registration
Regulatory consulting for medical device classification, technical documentation, product registration, and compliance with Thai FDA and ASEAN Medical Device Directive (AMDD) requirements.
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Food Supplement & Medical Food Registration
Regulatory pathway assessment and product registration support for food supplements, nutraceuticals, and medical food products.
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Cosmetic Notification & Compliance
Support for cosmetic product notification, labeling review, and regulatory compliance in accordance with Thai FDA cosmetic regulations.
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Herbal & Traditional Product Registration
Regulatory consulting for herbal medicinal products and traditional healthcare products.
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Product Classification & Regulatory Strategy
Strategic assessment of product classification, regulatory pathway, and submission requirements to optimize approval timelines and regulatory compliance.
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Dossier Preparation & Submission Support
Preparation, review, and gap analysis of regulatory dossiers in ACTD, CTD, CSDT, and applicable submission formats.
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Labeling & Artwork Compliance
Review of product labeling, IFU, packaging materials, and promotional claims to ensure regulatory compliance.
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Import License & Regulatory Licensing Support
Support for import permits, establishment licensing, and regulatory coordination with relevant authorities.
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Post-Marketing Regulatory Support
Regulatory maintenance services including product variations, renewals, adverse event reporting, and post-market compliance management.
OUR SERVICES
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Regulatory Affairs Consulting
Strategic regulatory planning, compliance management, and lifecycle support for healthcare products.
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Clinical Trial Regulatory Support
Support for Clinical Trial Application (CTA), ethics committee coordination, and regulatory submission activities.
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Market Access & Commercial Strategy
Advisory services for pricing, reimbursement, healthcare market access, and commercialization strategy.
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Distribution & Local Partnership Support
Support for local representation, distribution coordination, and market entry partnerships.
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Compliance & Regulatory Intelligence
Ongoing monitoring of regulatory updates, guideline changes, and compliance requirements across Thailand and ASEAN.
OUR PROCESS
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Regulatory Strategy
Product Assessment
Dossier Preparation
Regulatory Submission
Authority Review
Approval & Market Entry
INSIGHTS
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Drug Registration in Thailand: Regulatory Overview
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Medical Device Classification & Registration Requirements ​
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Clinical Trial Application Process in Thailand
ASEAN Regulatory Harmonization Updates
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