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Pharmaceutical Compliance & Consulting Services in Thailand
Getting a pharmaceutical product approved in Thailand isn’t easy — especially if you don’t have a local presence. That’s where Artixio steps in. We help pharma companies manage Thai FDA approvals, drug compliance, and market entry — all without setting up a local office. From early-stage compliance strategy to lifecycle management, we make sure your operations align with local laws and move forward smoothly.
Pharmaceuticals
End-to-End Pharmaceutical
Consulting in Thailand
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
End-to-End Pharma Consulting for Thai FDA Submissions
We help pharma companies make sense of the Thai market. Whether you’re figuring out how to register your drug or trying to fix a delayed approval, our role is to guide—not just give advice, but actually get involved.
Some teams come to us before submitting anything to the Thai FDA, asking us to review the documents and spot issues early. Others need support when something’s already stuck in review or if they’ve received a query from the authorities. We also help when something changes—like a product update, new label requirement, or renewal deadline. Instead of slowing you down, we find the simplest way through and keep things on track.
The way the Thailand FDA works is often different from what global teams are used to. We’ve learned through hands-on experience what works—and what doesn’t. That’s why we don’t just follow the rulebook; we use real-world insight to help you move through registrations and lifecycle filings with fewer delays.
Our Thailand Pharma Support Includes
- Regulatory strategy and classification
- Product Registration Affairs
- Pharmacovigilance
- CTD/eCTD dossier preparation
- Post-Marketing Surveillance
- Regulatory Intelligence
- Local agent coordination
- Regulatory Operations
- Label and packaging compliance
- Publishing & Submission Services
- Legal Representative
- HA Liaison (Health Authority Liaison)
- Quality Services
- Market Access
- Regulatory Testing
- Regulatory Staffing
- Global Regulatory Outsourcing
-
Performance Evaluation Reports (IVD
Medical Devices) - Active Safety Surveillance
- MDR Gap Assessment
- GMP and Regulatory Compliance
- GxP Compliance & Regulations
- Market Research
- Product Lifecycle Maintenance Services
- Advertisement and Promotional Material Review
- IND (Investigational New Drug)
- Thai FDA meeting representation
Pharma Market Entry & MAH Support in Thailand
If you’re trying to enter the pharma market in Thailand, we help you figure out what’s needed right from the start. That includes checking if your product needs a full registration, handling local representation, and guiding you through Thai FDA expectations.
Some companies need help before filing anything—others reach out when submissions get delayed. We also support Marketing Authorization (MA) and can act as your MAH if required. From the first step to final approval, we help you move forward without guesswork.
FAQS About Pharma Regulatory in Thailand
1. Can you help us register a new pharmaceutical product in Thailand?
Yes, we help companies with product registrations—whether it’s your first product or part of a larger portfolio. We assist with planning, document preparation, and coordinating the process with local teams or agents.
2. We’re already in the Thai market. Do you also help with ongoing updates or changes?
Yes. We often step in to support things like renewals, variations, labeling updates, or additional documentation if requested by the authorities. We can work with your internal team or existing partners.
3. Do you work only with companies outside Thailand?
No. Some of our clients are based in Thailand, and others manage things from overseas. It doesn’t really matter where you sit — we just make sure the process fits how you work.
4. How do you handle communication with Thai authorities?
We either work directly with them or support your in-country team with the right guidance, depending on the setup. We make sure messages are clear, complete, and aligned with what the authority expects.
5. Does the Thai FDA accept eCTD format for pharma submissions?
Thai FDA is moving toward digital submission, but not all product types require eCTD yet. We stay updated on evolving requirements and advise the right format for your product.
Why Choose Artixio?
We know how Thai FDA works — beyond just the paperwork.
Help review CTD format as per Thai-specific structure
Guidance on variation filing types accepted by TFDA
Support with local labeling, formatting, and agent coordination.
Track submission status and follow up proactively with local agents
Regulatory Expertise Across
Multiple Countries
United States
Brazil
European Union
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