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Lifesciences Compliance Services in Thailand
End-to-end compliance services in Thailand for life sciences products — from Thai FDA submissions to MAH support and market entry consulting. We at Artixio aim to support local and foreign manufacturers in the Thailand market with simple compliance strategies and hassle-free regulatory procedures.
Thailand
Regulatory Compliance Support for Market Entry in Thailand
If you’re planning to bring your product into Thailand, getting through the Thai FDA requirements is a big step. At Artixio, we help companies — both local and international — figure out what’s really needed to stay compliant. From MAH setup to preparing the right documents, we take care of the tricky parts so you can focus on your product. No jargon, no guesswork — just clear support that gets things moving.
Artixio helps companies whether local or international, handle healthcare compliance requirements in Thailand. We have helped companies — small teams and big names alike — figure out what’s actually needed. From that first TFDA form to sorting updates later, we’re here to help you stay on track without all the guesswork.
Thai FDA Healthcare Consulting & Compliance Services
Thailand’s growing healthcare sector makes it a key market for global life sciences. The Thai FDA (TFDA) regulates pharmaceuticals, medical devices, cosmetics, nutrition, and wellness products through divisions like the Medical Device Control Division (MDCD) and ASEAN Cosmetic Directive (ACD). Veterinary products are managed by the Department of Livestock Development (DLD). Our team helps you plan and manage compliance submissions based on current Thai FDA guidelines.
The table below depicts the various healthcare and life sciences industries and their regulatory authorities in Thailand
| Industry | Regulatory Body | Responsibilities |
|---|---|---|
| Pharmaceuticals | Thai FDA under Ministry of Health | Grants drug approval and market access. Ensures safety and efficacy of drug. |
| Medical Devices | Thai FDA with assessment of technical data by Medical Device Control Division (MDCU) | Regulates the Medical devices in the Philippian market. |
| Wellness products | Thai FDA under Food Act B.E 2522 (1979) | Confirms the quality and ensures the safety and efficacy of wellness products. |
| Cosmetics | FDA (Philippines) | Ensures the quality, standards, purity of cosmetics in Philippian market. |
| Animal care and Veterinary products | Dept of Livestock Development (DLD) under Ministry of Agriculture and Cooperatives | Regulates the veterinary products in the Thai market by confirming its safety, efficacy and quality. |
Trusted Thai FDA Support for Life Sciences Companies
Looking to hire an ISO consultant for product compliance in Thailand for TFDA submissions? Artixio provides in-country expertise and working with us gives you more than just regulatory advice — it gives you a team on the ground in Thailand who knows how to get things done. We help local and international companies register pharmaceuticals, medical devices, cosmetics, supplements, and veterinary products with the Thai FDA and other relevant bodies.
From product registration to post-approval compliance, we’re with you through every stage. Our Thailand team answers your regulatory questions clearly, manages timelines, and supports your product across its full lifecycle — including renewals, variations, and license updates.
With Artixio, your launch in Thailand becomes smoother, faster, and fully compliant with local laws. We also provide support as an ISO consultant for product compliance in Thailand, helping businesses meet both regulatory and international quality standards.
Thailand's Regulatory Approval and Submission Process for Compliance
Service Category
- Regulatory Affairs
- Market access
- Pharmaco-vigilance
- Quality Assurance
Pre-registration services
- Regulatory Intelligence
- Market assessment
- Technical and medical writing
- Local Agent Appointment
- Document Review
- Risk Management
- Pre-submission to FDA (Philippines)
- IND
- NDA
- Dossier Gap Analysis
- Technical Due Diligence
Registration services
- Product registration in Philippines
- Submission of registered documents
- to FDA (Philippines)
- HA liaison and legal
- Medical and Technical Writing
- Labelling and Artwork
- ECTD/CTD preparation and submission to FDA (Philippines)
- Compliance check
Post-registration services
- Compliance monitoring
- Post-marketing surveillance in Philippines
- Product Recall Management
- Lifecycle Maintenace
- Line extensions
- Importer/ Distributer Assistance in Philippines
MAH Services & TFDA Local Authorized Requirements
If you’re looking to register your product in Thailand without a local office, Artixio can act as your Market Authorization Holder (MAH) and local authorized representative, managing all your TFDA submission requirements. As your in-country partner, we assist with:
- End-to-end MAH services in Thailand, including renewals and variations
- Preparing and submitting regulatory dossiers
- Addressing Thai compliance guideline queries quickly
- Our team develops customized regulatory compliance strategies around your product type and how TFDA handles such cases in Thailand.
- Managing responses from the Thai FDA during the review process
- ISO consulting for product compliance, documentation, and quality systems alignment in Thailand
- In-country support as a Thailand local authorized representative for TFDA submissions and ongoing compliance
We work closely with manufacturers, distributors, and local agents to support market authorization in Thailand and reduce approval timelines.
Our Compliance Services In Thailand
Why Choose Artixio for Regulatory Compliance in Thailand?
FAQs
How can international companies meet regulatory compliance requirements in Thailand?
Foreign companies must partner with a local representative or regulatory consultant for TFDA submissions and approvals. This ensures compliance with Thai laws and simplifies product registration and market entry.
Who can act as a Market Authorization Holder (MAH) in Thailand?
Only a locally registered company in Thailand can act as an MAH. If you don’t have a local presence, you can appoint a regulatory compliance consulting company in Thailand, like Artixio, to serve as your MAH.
What documents are needed for regulatory compliance submissions to TFDA?
It depends on what you’re registering, but most submissions to the Thai FDA require a core dossier, manufacturing and safety documents, Thai translations (especially for labels), and proof that your company is authorized to apply. Some product categories may need extra paperwork, depending on the approval route.
How does your Regulatory Team manage international submissions?
Our regulatory experts are based locally in key markets globally with 15-35 years of experience in successfully registering and managing lifecycle for complex products across pharmaceuticals, biologics, devices and consumer products. Our clients not only benefit from regional insights but appointed Local Legal Representation (LLR) to manage health authority submissions and relations.
How do you stay updated with global regulatory changes?
Artixio has internal regulatory intelligence platform, Dvarka, that tracks global regulatory changes. The platform hosts,
- Current regulations, directives, regulatory insights
- Track changes in regulations, new guidelines, notifications from health authorities worldwide
- Insights by our Regional Regulatory Experts from their experience, attendance to Conference, Seminars, Trade Shows, HA Organized Trainings and Events
- Artixio’s expert opinions and Case Studies
Industries We Serve in the Thailand
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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