Specialized Regulatory Advisory Services
Three focused practice areas addressing distinct compliance challenges in the Thai regulatory environment.
Return HomeOur Advisory Methodology
A systematic approach to regulatory compliance that emphasizes thorough analysis, precise documentation, and strategic coordination.
Each regulatory engagement follows a structured methodology designed to navigate Thai administrative frameworks efficiently. We begin with comprehensive assessment of applicable requirements, proceed through meticulous documentation preparation aligned with agency specifications, coordinate strategic submission timing, and provide ongoing support through approval and implementation phases.
Our approach integrates legal analysis with practical understanding of agency procedures. This combination allows us to anticipate common compliance issues, prepare submissions that address regulatory expectations, and provide realistic timeline guidance based on actual processing experiences.
The methodology adapts to each practice area's unique requirements while maintaining consistent standards for documentation quality, client communication, and regulatory coordination. Clients receive clear explanations of compliance pathways, transparent discussion of strategic considerations, and accessible counsel throughout the engagement.
Pharmaceutical & Medical Device Regulation
Advisory on the registration and regulatory compliance of pharmaceutical products and medical devices in Thailand, covering FDA applications, clinical trial approvals, labelling requirements, and post-market surveillance obligations. Suitable for pharmaceutical manufacturers, medical device importers, and biotech companies entering the Thai market.
Key Benefits
- Registration pathway analysis with timeline estimates based on product classification
- FDA application preparation including technical documentation and label compliance
- Clinical trial approval coordination and ethics committee requirements
- Post-market surveillance framework and adverse event reporting guidance
Process Steps
- Initial assessment of product classification and applicable regulatory pathway
- Technical documentation review and preparation for FDA submission requirements
- Application filing and coordination with Thai FDA throughout review process
- Post-approval compliance guidance including surveillance and reporting obligations
Advisory Fee
Typical Duration
6-12 months
Public Procurement & Government Contracts
Counsel on participation in Thai government procurement processes, covering tender documentation preparation, compliance with the Government Procurement and Supplies Management Act, bid protest procedures, and contract performance advisory. Designed for companies seeking to engage with government agencies and state enterprises.
Key Benefits
- Procurement eligibility review and qualification assessment for tender participation
- Tender documentation preparation aligned with procurement act requirements
- Bid protest procedure guidance and administrative review representation
- Contract performance obligations and compliance advisory
Process Steps
- Eligibility assessment and procurement qualification documentation review
- Tender preparation including technical specifications and financial proposals
- Submission coordination and bid opening attendance where beneficial
- Award phase support and contract negotiation guidance if successful
Advisory Fee
Typical Duration
3-6 months
Retirement & Provident Fund Advisory
Advisory on the establishment and administration of provident funds and retirement benefit programmes under Thai law, covering fund registration with the SEC, investment policy drafting, member communication frameworks, and regulatory reporting obligations. Suitable for employers setting up or restructuring employee retirement benefits.
Key Benefits
- Fund structure options memorandum covering different provident fund models
- SEC registration preparation and fund establishment documentation
- Investment policy framework development within regulatory parameters
- Member communication protocols and ongoing reporting requirements
Process Steps
- Assessment of company situation and retirement benefit objectives
- Fund structure recommendation and policy framework development
- SEC registration application preparation and submission coordination
- Implementation support and ongoing compliance guidance
Advisory Fee
Typical Duration
2-4 months
Service Comparison
Understanding which advisory service aligns with your regulatory compliance needs.
| Feature | Pharmaceutical | Procurement | Retirement Fund |
|---|---|---|---|
| Primary Agency | Thai FDA | Government Agencies | SEC Thailand |
| Typical Timeline | 6-12 months | 3-6 months | 2-4 months |
| Advisory Fee | ฿55,000 | ฿35,000 | ฿22,000 |
| Registration Required | |||
| Ongoing Compliance | |||
| Technical Documentation | |||
| Best For | Product Manufacturers | Government Contractors | Employer Benefit Plans |
Selecting the Right Service
Pharmaceutical Service
Choose this if you manufacture or import pharmaceutical products or medical devices requiring Thai FDA approval for market entry.
Procurement Service
Choose this if you seek to bid on government contracts or supply products/services to Thai government agencies.
Retirement Fund Service
Choose this if you need to establish or restructure provident fund programmes for employee retirement benefits.
Shared Practice Standards
Quality principles applied across all three advisory service areas.
Regulatory Accuracy
All submissions undergo internal quality review to verify compliance with current agency requirements and procedural specifications before filing.
Clear Communication
Regular updates on submission status, agency communications, and timeline developments throughout the engagement period.
Confidentiality
Client information protected under attorney-client privilege and firm confidentiality protocols exceeding statutory requirements.
Realistic Timelines
Timeline estimates based on actual agency processing experiences rather than theoretical best-case scenarios.
Fixed-Fee Transparency
Clearly documented fee structures with no hourly billing surprises for defined engagement scopes.
Senior Counsel Access
Direct work with senior attorneys throughout engagements rather than delegation to junior staff members.