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Lifesciences Compliance Services in Thailand
Thailand
Regulatory Authorities In Thailand:
In the recent years Thailand has shown a great development in the healthcare system which provides significant opportunity for the healthcare manufacturers for their products to develop globally in Thailand. The principle regulatory authority in Thailand is the Thai FDA which regulates a wide range of industries such as the pharmaceuticals, medical devices, wellness products, cosmetics. These industries are regulated by the Thai FDA under various other authorities such as Medical Device Control Division (MDCU) for medical devices, ASEAN Cosmetic Directive (ACD) for cosmetics, etc. Whereas the Animal care and veterinary products are regulated by the Dept of Livestock Development (DLD).
| 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. |
Optimize Your Regulatory Journey With Artixio:
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
Our Services
Why Artixio?
Industries We Serve in the Thailand
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What are key components of global Regulatory Affairs?
Global Regulatory Affairs encompass a variety of activities, including regulatory intelligence and strategy, regulatory and technical writing, dossier gap analysis and preparation, GMP application, publishing and submission to health authorities, artwork and label review, ad promo review, product lifecycle management, health authority liaison and response to queries, legal representation / license holding, regulatory information management and other operational activities to ensure product compliance across multiple markets and therapeutic area / applications.
How do you support Regulatory Affairs across multiple countries?
Artixio’s regulatory intelligence platform is regularly updated with regulations from global heatlh authorities including any new changes in regulations. Coupled with Artixio’s regulatory experts based in 120+ countries and experience in successfully registering and maintaining compliance for complex products, centralized global project management best practices, Artixio supports Regulatory Affaris across multiple countries.
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.
What challenges do companies face in global regulatory affairs and how do you address them?
Few challenges that companies face while managing global regulatory affairs include, but not limited to, lack of knowledge of local regulations, lack of experience, regional language and cultural nuances, lack of trusted expert with global perspective, irregular processes, inconsistency in documents, intellectual property security, quality of documentation, transparency, maintaining compliance with changing regulations, products portfolio revenue versus cost of compliance/ ROI and others.
Artixio addresses these challenges by providing flexible, budget friendly and timely compliance solutions and regulatory affairs services using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.
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
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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