Complex documentation
Navigating the highly technical requirements of ACTD and ICH-CTD standards.
24+ years of regulatory expertise in Thailand
Thai FDA approval, handled end to end
Ready. Register. Grow.
No regulatory team, no idea where to start, or a dossier that keeps coming back? We run the entire process — dossier audit, submission, query management, market authorization and post-approval support.
24+
Years of expertise
Combined senior expertise in international and local regulatory affairs
30–50%
Faster
Time-to-market, through optimized regulatory workflows
~100%
Approval rate
Our pre-screening system minimizes rejection risk
6
Product sectors
Pharma, devices, food & supplements, cosmetics, herbals, hazardous substances
The problem we solve
The Registration Wall
Global innovators entering the Thai market run into the same four bottlenecks.
High failure rate
Minor errors can lead to total application rejection, forcing companies to restart.
Regulatory shift
Frequent updates to Thai FDA and international medical device regulations are hard to track.
Time-to-market delays
Approval waiting periods of 6–24 months mean substantial lost revenue.
How we work
Ready. Register. Grow.
An integrated service model that supports clients throughout the entire product lifecycle.
- READY01
Prepare with confidence
Technical dossier audits and gap analyses, regulatory pathway and classification assessment, ACTD/ICH-CTD compliance review, pre-submission readiness assessment, clinical trial regulatory readiness, and submission planning.
- REGISTER02
Navigate with precision
Thai FDA registration and product submissions, regulatory document preparation and coordination, authority communications, deficiency and query management, Market Authorization Holding, and post-approval regulatory support.
- GROW03
Expand with strategy
Product lifecycle management, portfolio expansion and new product registration, regulatory variations and maintenance, market expansion strategies, ongoing compliance, and strategic market access support.
Our core services
What we do for you
Three service pillars covering everything from pre-submission to post-approval.
I
Regulatory & Licensing Services
From dossier gap analysis and registration to variations, advertising approval, and manufacturing / import / storage facility licences.
Read moreII
Market Authorization Holding (MAH)
Enter the Thai market immediately — without a local office or legal entity. We act as your licence holder and legal representative.
Read moreIII
Clinical Operation Services
Full clinical operation management — document preparation, IRB/EC and Thai FDA submissions, and clinical site management.
Read moreWhy us
Why global innovators partner with us
Executive-led industry expertise
Our leadership brings first-hand experience from pharmaceutical and medical technology companies, combining regulatory expertise with commercial priorities.
First-time-right scientific precision
A systematic, science-driven dossier review aligned with ACTD and ICH-CTD identifies gaps before submission — fewer queries, fewer delays.
Global standards, local expertise
International regulatory standards combined with deep knowledge of Thailand's regulatory environment.
End-to-end lifecycle support
More than registration — early strategy, accelerated market entry, post-approval compliance, and portfolio scaling.
Strategic, transparent, commercially aligned
Clear regulatory strategies, realistic timelines and transparent communication for confident business decisions.
Comprehensive sector coverage
Pharmaceuticals & biologics, medical devices, food & dietary supplements, cosmetics, advanced therapeutics, and hazardous substances.
Insights
Latest regulatory updates
Announcements and practice notes that affect your product registration.
Regulatory Updates
What you actually need before a Thai FDA submission
The documents that get rejected most often are not the hardest ones — they are the incomplete ones. Here is the checklist our team runs before every submission.
Insights
Entering Thailand without a local entity: how the MAH model works
Setting up a Thai legal entity takes time and capital. The Market Authorization Holding model lets you sell first and decide on investment later.
Insights
GMP inspection readiness: the findings we see most often
Thai FDA and PIC/S GMP inspections turn up the same handful of findings again and again. Knowing them in advance beats fixing them afterwards.
Start with a 30-minute conversation
Tell us what your product is and when you want it on the Thai market. We will assess the regulatory pathway, the realistic timeline and the documents you need — at no cost.
Call 064-597-9451 · healthhappiness.ltd@gmail.com