FDA (Food and Drug Administration)
FDA Approval Services
The Food and Drug Administration (FDA) is a crucial regulatory agency that oversees the safety of health products in Thailand. All products related to food, drugs, cosmetics, medical devices, and dietary supplements must obtain FDA approval before they can be legally marketed.
Our company provides comprehensive services for obtaining FDA approval for various types of products through a team of experts experienced in FDA regulations and requirements. We help ensure that the approval process goes smoothly and quickly, reducing the risk of rejection and helping your products enter the market legally.
Food Product Approval Services
Obtaining FDA approval for food products is an essential step that business operators must take to ensure that food products are safe and meet the standards required by law.
Types of Food Product Approvals
Food Serial Number Registration – For specifically controlled foods and foods with defined quality or standards
Food Production License – For food production facilities
Food Import License – For importers of foreign food products
Food Advertisement Approval – For advertising food products through various media
Our Services
Regulatory Consultation – Providing guidance on regulations and requirements related to food products
Document Preparation – Assisting in preparing all necessary documents such as ingredient formulations, production processes, test reports, and other documents
Label and Packaging Review – Checking the accuracy of labels and packaging to comply with FDA requirements
Document Submission and Follow-up – Submitting documents to the FDA and tracking progress until approval is obtained
Amendments and Appeals – Providing assistance in case of document amendment requests or application rejections
Requirements and Necessary Documents
Identification documents of the applicant and business operator
Documents detailing production or import facilities
Detailed ingredient formulations and production processes
Label and packaging samples
Test reports from certified laboratories
Good Manufacturing Practice (GMP) certification for production facilities
Other documents as specified by the FDA
Pharmaceutical Product Approval Services
Obtaining FDA approval for pharmaceutical products is a complex and rigorous process, as drugs directly affect consumers’ health and safety.
Types of Pharmaceutical Product Approvals
Drug Registration – For new drugs, generic drugs, biological products, and other drugs
Drug Manufacturing License – For drug manufacturing facilities
Drug Import License – For importers of foreign drugs
Drug Sales License – For drug distribution locations
Drug Advertisement Approval – For advertising pharmaceutical products through various media
Our Services
Product Assessment and Analysis – Evaluating product properties and information to determine registration strategies
Regulatory Consultation – Providing guidance on regulations and requirements related to pharmaceutical products
Technical Document Preparation – Preparing necessary technical documents such as clinical study reports, safety data, efficacy information, and other documents
Document Submission and Follow-up – Submitting documents to the FDA and tracking progress until approval is obtained
Facility Inspection Support – Helping prepare for FDA inspections of manufacturing or import facilities
Amendments and Appeals – Providing assistance in case of document amendment requests or application rejections
Requirements and Necessary Documents
Identification documents of the applicant and business operator
Documents detailing production or import facilities
Information about product development
Clinical study information (if necessary)
Information about drug safety and efficacy
Information about manufacturing processes and quality control
Label samples and package inserts
Test reports from certified laboratories
Good Manufacturing Practice (GMP) certification for production facilities
Other documents as specified by the FDA
Cosmetic Product Approval Services
Obtaining FDA approval for cosmetic products is an important step for business operators who want to legally market cosmetic products in Thailand.
Types of Cosmetic Product Approvals
Cosmetic Notification – For general cosmetic products
Cosmetic Production License – For cosmetic manufacturing facilities
Cosmetic Import License – For importers of foreign cosmetic products
Cosmetic Advertisement Approval – For advertising cosmetic products through various media
Our Services
Regulatory Consultation – Providing guidance on regulations and requirements related to cosmetic products
Ingredient Verification – Checking product ingredients to ensure compliance with FDA requirements
Document Preparation – Assisting in preparing all necessary documents such as ingredient formulations, production processes, test reports, and other documents
Label and Packaging Review – Checking the accuracy of labels and packaging to comply with FDA requirements
Document Submission and Follow-up – Submitting documents to the FDA and tracking progress until approval is obtained
Amendments and Appeals – Providing assistance in case of document amendment requests or application rejections
Requirements and Necessary Documents
Identification documents of the applicant and business operator
Documents detailing production or import facilities
Detailed ingredient formulations (both common and scientific names)
Label and packaging samples
Safety test reports (if necessary)
Good Manufacturing Practice (GMP) certification (if available)
Other documents as specified by the FDA
Medical Device Approval Services
Obtaining FDA approval for medical devices is a complex and stringent process, as medical devices are directly related to the health and safety of users.
Types of Medical Device Approvals
Medical Device Manufacturing License – For medical device manufacturing facilities
Medical Device Import License – For importers of foreign medical devices
Medical Device Registration – For medical devices requiring registration
Listing – For medical devices requiring detailed listing
Notification – For medical devices requiring notification
Medical Device Advertisement Approval – For advertising medical devices through various media
Our Services
Medical Device Classification – Assisting in classifying medical devices by risk level (Class I, II, III) to determine the appropriate approval process
Regulatory Consultation – Providing guidance on regulations and requirements related to medical device products
Technical Document Preparation – Preparing necessary technical documents such as design information, safety data, efficacy information, and other documents
Document Submission and Follow-up – Submitting documents to the FDA and tracking progress until approval is obtained
Facility Inspection Support – Helping prepare for FDA inspections of manufacturing or import facilities
Amendments and Appeals – Providing assistance in case of document amendment requests or application rejections
Requirements and Necessary Documents
Identification documents of the applicant and business operator
Documents detailing production or import facilities
Technical specifications of the medical device
Information about product design and development
Information about manufacturing methods and quality control
Risk assessment reports
Safety and efficacy test reports
User manuals and product labels
Relevant standard certifications (e.g., ISO 13485)
Other documents as specified by the FDA
Dietary Supplement Approval Services
Obtaining FDA approval for dietary supplements is an essential step for business operators who want to legally market dietary supplement products in Thailand. Dietary supplements are categorized as food products under Thai law.
Types of Dietary Supplement Approvals
Food Serial Number Registration – For all types of dietary supplements
Food Production License – For dietary supplement manufacturing facilities
Food Import License – For importers of foreign dietary supplements
Food Advertisement Approval – For advertising dietary supplement products through various media
Our Services
Regulatory Consultation – Providing guidance on regulations and requirements related to dietary supplements
Product Classification – Helping classify dietary supplement products according to FDA criteria
Ingredient Verification – Checking product ingredients to ensure compliance with FDA requirements
Document Preparation – Assisting in preparing all necessary documents such as ingredient formulations, production processes, test reports, and other documents
Label and Packaging Review – Checking the accuracy of labels and packaging to comply with FDA requirements
Document Submission and Follow-up – Submitting documents to the FDA and tracking progress until approval is obtained
Claim Guidance – Providing advice on appropriate and legally compliant product claims
Amendments and Appeals – Providing assistance in case of document amendment requests or application rejections
Requirements and Necessary Documents
Identification documents of the applicant and business operator
Documents detailing production or import facilities
Detailed ingredient formulations (both common and scientific names)
Detailed production processes
Label and packaging samples
Laboratory test reports
Good Manufacturing Practice (GMP) certification for production facilities
Other documents as specified by the FDA
Why Choose Our Services
Expertise – Our team has over 10 years of expertise and experience in obtaining FDA approvals
High Success Rate – We have a 95% success rate in obtaining approvals
Time-Saving – We help minimize the time required for approval
Comprehensive Services – We provide complete services from consultation to approval
Close Monitoring – We closely track progress and keep you informed throughout the process
Problem-Solving – We have experience in resolving issues that may arise during the approval process
Good Relationships – We maintain good relationships with FDA agencies, which helps ensure smooth processes
Contact Us
If you require our services or need more information about FDA approvals, please contact us at:
Phone: 080-765-6400
Email: info@thaivisalegal.com
Website: www.thaivisalegal.com
Office: 83 Sukhumvit 93, Bangchak, Prakanong, Bangkok 10260 Thailand
Business Hours:
Monday – Friday: 8:30 AM – 5:30 PM
Saturday: 9:00 AM – 1:00 PM (By appointment only)
Free initial consultation! Contact us today to efficiently plan your product approval process.