New Product Registration
Comprehensive Services for New Product Registration
New product registration is a crucial step that entrepreneurs must complete before legally bringing their products to market. Whether it’s food products, pharmaceuticals, cosmetics, or medical devices, product registration is a complex process that requires specialized expertise.
Our company provides comprehensive services for registering various types of new products through a team of experts with experience and knowledge of requirements and regulations from relevant regulatory authorities. We help make your product registration process smooth, fast, and efficient.
Food Product Registration Services
Registering new food products involves obtaining approval from the Food and Drug Administration (FDA) before marketing food products. This process is important and legally required.
Types of New Food Product Registration
Food Serial Number Registration – For specifically controlled foods and foods with defined quality or standards
Food Notification – For foods requiring notification
Imported Food Registration – For food products imported from abroad
Novel Food Registration – For foods without a history of consumption in Thailand
Steps for New Food Product Registration
Preliminary Product Assessment
Analyzing the type of food product
Checking ingredients and safety
Determining the appropriate registration approach
Document Preparation
Preparing ingredient formulation documents
Preparing manufacturing process documents
Creating labels and packaging according to requirements
Preparing quality and safety analysis documents
Document Submission
Submitting registration applications to the Food and Drug Administration
Paying registration fees
Tracking application status
Amendments and Additional Information
Correcting documents as requested by officials
Providing additional information or documents as needed
Approval
Receiving food serial numbers or registration certificates
Preparing labels with food serial numbers
Planning production and marketing
Our Services
Regulatory Consultation – Providing guidance on regulations and requirements related to food products
Product Assessment – Analyzing products to determine appropriate registration approaches
Formula and Production Process Development – Advising on formula and production process development to meet requirements
Document Preparation – Preparing all necessary documents for registration
Document Submission and Follow-up – Handling document submission and tracking application status
Problem Solving – Providing assistance in resolving issues that may arise during the registration process
Pharmaceutical Product Registration Services
Registering new pharmaceutical products is a complex and rigorous process, as pharmaceutical products directly affect consumer health and safety. Registration requires comprehensive and reliable scientific data.
Types of Pharmaceutical Product Registration
New Drug Registration – For drugs with new active ingredients or new indications
New Generic Drug Registration – For generic drugs with the same components as original drugs whose patents have expired
New Biological Product Registration – For pharmaceutical products produced from living organisms
New Herbal Medicinal Product Registration – For pharmaceutical products containing herbal ingredients
Steps for New Pharmaceutical Product Registration
Research and Studies
Pre-clinical Studies
Clinical Studies
Drug Stability Studies
Document Preparation
Preparing technical documents (Common Technical Document – CTD)
Preparing quality information
Preparing safety information
Preparing efficacy information
Document Submission
Submitting registration applications to the Food and Drug Administration
Paying registration fees
Tracking application status
Evaluation and Review
Evaluation of scientific documents
Verification of information accuracy
Benefit and risk assessment
Approval and Monitoring
Receiving drug registration certificates
Post-marketing surveillance
Our Services
Registration Strategy Consultation – Planning registration strategies appropriate for the product
Clinical Study Design – Providing guidance on appropriate clinical study design
CTD Document Preparation – Preparing high-quality Common Technical Documents
Coordination with Regulatory Authorities – Coordinating with the Food and Drug Administration on your behalf
Problem Solving – Resolving issues and obstacles that may arise during the registration process
Post-Approval Monitoring – Providing assistance in safety monitoring and post-approval reporting
Cosmetic Product Registration Services
Registering new cosmetic products is a necessary process for entrepreneurs who want to legally bring cosmetics to market. In Thailand, all cosmetics must be notified to the Food and Drug Administration before distribution.
New Cosmetic Product Registration Process
Ingredient Verification
Checking all ingredients in the product
Verifying limitations and prohibitions of various ingredients
Confirming ingredient safety
Document Preparation
Preparing detailed and accurate ingredient formulations
Preparing labels and packaging according to requirements
Preparing quality and safety certification documents
Cosmetic Notification
Submitting cosmetic notification applications to the Food and Drug Administration
Paying notification fees
Receiving cosmetic notification certificates and notification numbers
Compliance with Post-Notification Requirements
Creating labels with complete information as required by law
Maintaining production and quality control records
Monitoring product safety in the market
Our Services
Regulatory Consultation – Providing guidance on regulations and requirements related to cosmetics
Ingredient Assessment – Checking and evaluating product ingredients for safety and regulatory compliance
Formula Development – Advising on cosmetic formula development to meet requirements
Notification Document Preparation – Preparing all necessary documents for cosmetic notification
Document Submission and Follow-up – Handling notification document submission and tracking status until approval
Labeling Guidance – Providing guidance on creating labels and packaging that comply with requirements
Problem Solving – Providing assistance in resolving issues that may arise during the notification process
Medical Device Registration Services
Registering new medical devices is a complex process requiring specialized expertise, as medical devices directly relate to the health and safety of users.
Types of Medical Device Registration
Medical Device Manufacturing License – For domestic medical device manufacturers
Medical Device Import License – For importers of foreign medical devices
Medical Device Registration – For medical devices requiring registration (high risk)
Notification of Details – For medical devices requiring notification of details (moderate risk)
Medical Device Notification – For medical devices requiring notification (low risk)
Steps for New Medical Device Registration
Medical Device Classification
Analyzing product features and intended use
Determining the risk level of the medical device (Class I, II, III, IV)
Determining the appropriate registration type
Technical Document Preparation
Preparing product specification documents
Preparing risk assessment reports
Preparing safety and efficacy test reports
Preparing user manuals and labels
Application Submission
Submitting registration applications to the Food and Drug Administration
Paying relevant fees
Tracking application status
Evaluation and Inspection
Evaluation of technical documents
Inspection of manufacturing or import facilities (if necessary)
Quality system assessment
Approval and Monitoring
Receiving licenses, notification of details certificates, or notification certificates
Post-market safety monitoring
Adverse event reporting
Our Services
Medical Device Classification – Assisting in classifying medical devices and determining risk levels
Regulatory Consultation – Providing guidance on relevant regulations and requirements
Conformity Assessment – Evaluating product conformity with relevant standards
Technical Document Preparation – Preparing all necessary technical documents for registration
Document Submission and Follow-up – Handling document submission and tracking status until approval
Post-Marketing Surveillance Guidance – Providing guidance on post-marketing safety monitoring systems
Problem Solving – Providing assistance in resolving issues that may arise during the registration process
Registration Requirements Consultation Services
In addition to registration services for various product types, we also provide consultation services on registration requirements covering all aspects related to product registration.
Our Consultation Services
Preliminary Product Assessment
Analyzing product types and characteristics
Determining appropriate registration types
Assessing registration feasibility
Regulatory Consultation
Providing information on relevant regulations and requirements
Updating on the latest regulatory changes
Providing guidance on regulatory compliance
Product Development Consultation
Providing guidance on product development to meet requirements
Identifying potential registration obstacles
Suggesting solutions
Testing and Study Consultation
Providing guidance on tests necessary for registration
Providing guidance on clinical study design (if necessary)
Recommending certified testing laboratories
Documentation Consultation
Providing guidance on documents necessary for registration
Reviewing and providing feedback on prepared documents
Providing guidance on creating high-quality documents
Benefits of Consultation
Time and Cost Savings – Reducing the risk of registration rejection which can result in additional time and expenses
Clear Understanding of Requirements – Clear understanding of relevant requirements and regulations
Efficient Planning – Ability to plan registration and product development efficiently
Reduced Business Risk – Helping to reduce investment risk and the development of products that may not be approved
Increased Chances of Success – Increasing chances of first-time registration approval
Consultation Formats
Initial Consultation – Preliminary consultation to evaluate products and provide general information
In-depth Consultation – Analysis and detailed recommendations regarding product registration
Ongoing Consultation – Continuous consultation throughout the product development and registration process
Seminars and Training – Seminars and training on product registration requirements
Why Choose Our Services
Expertise and Experience – Our team has over 10 years of expertise and experience in registering various types of products
High Success Rate – We have a 95% success rate in new product registration
Comprehensive Services – We provide complete services from consultation to approval
Up-to-date Knowledge – We regularly track changes in regulations and requirements
Extensive Network – We have a collaborative network with experts and certified laboratories
Clear Communication – We communicate clearly and transparently with clients throughout the process
Value for Money – Our services help save time and expenses in the long run
Contact Us
If you are interested in new product registration services or need consultation, 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 new product registration.