|Pacific Legal Group's pharmacists , lawyers and supporting registration personnel specialize in preparing and submitting applications to the Thai Food and Drug Administration (Thai FDA) in the following areas:
- FOOD SUPPLEMENTS
- ANIMAL HEALTH
- NARCOTIC AND PSYCHOTROPIC SUBSTANCES
- MEDICAL DEVICES
- TOXIC SUBSTANCES
They have established good connections with the staff of the Thai FDA as well as the testing, science, and medical research facilities of the Thai FDA.
Pacific Legal Group can expedite the progress of regulatory filings through the Thai FDA and speed up access to Thai markets.
Pre-filing Document Review
Prior to filing registration applications, Pacific Legal Group reviews documents and other materials received from the manufacturer, and provides advice regarding the category into which the product will be placed by the Thai FDA as well as what additional documents, if any, the Thai FDA will require.
Through our procedures to insure that all application files are complete, we make substantial efforts to reduce and eliminate time loss caused by Thai FDA requests for additional information.
Pacific Legal Group makes a firm commitment to its clients to register products with the Thai FDA in the shortest possible time.
Reports and Meetings
Pacific Legal Group prepares monthly and other reports as agreed for its clients on the progress of all product registration applications. Pacific Legal Group also has meetings with its clients as frequently as they require.
Pacific Legal Group provides all the services required to maintain the ongoing registration status of products after they have been registered with the Thai FDA.
Greater Mekong Region
Pacific Legal Group also prepares, submits, and follows up applications for registration of products with the food and drug regulatory authorities of the Greater Mekong Region countries (Vietnam, Cambodia, Laos and Myanmar).
Pacific Legal Group prepares and submits applications to the Thai FDA for approval of product advertising.
In addition to applications for product registration licenses, Pacific Legal Group also prepares, files and follows up applications for the additional licenses required by the Thai FDA, such as manufacturing licenses for local production and certificates of free sale for export, as well as licenses to import products into Thailand.
Pacific Legal Group also has experience with the Thai FDA procedures for transferring existing registration licenses.
For those companies which do not have an office in Thailand, Pacific Legal Group can hold the necessary import and registration licenses. These services are always provided pursuant to a retainer agreement which requires Pacific Legal Group to transfer the licenses immediately upon request.
SMP and Bioequivalence
The services which Pacific Legal Group provides include SMP monitoring for new drug products.
Pacific Legal Group also provides bioequivalence studies for new generic drug products.
Registration Dossier Preparation
Pacific Legal Group's pharmacists prepare registration dossiers in compliance with Thai FDA requirements for companies which do not have an in-house regulatory staff.
General Thai FDA Matters
Pacific Legal Group provides consulting services on all general matters relating to the Thai FDA and the laws under which it operates.
Pacific Legal Group's staff can translate, into English or Thai, all documents such as product labels and package inserts. Arrangements can be made through our office for translation into other languages.
Animal Health Drug Product Registration Services
Pacific Legal Group's staff includes pharmacists who specialize in the registration of animal health drug products with the Thai FDA .
Pacific Legal Group provides specialized services for the following types of animal health drug products.
Our pharmacists register drugs and biological products with the Thai FDA.
Companion Animal Products
Our Pharmacists register drug and hazardous substances for companion animals with the Thai FDA.
Pharmaceutical Raw Materials (Active/Inactive)
Our pharmacists register pharmaceutical raw materials for animal health drug products with the Thai FDA.
In addition to applications for product registration licenses, Pacific Legal Group also prepares, files and follows up applications for the additional licenses required by the Thai FDA such as manufacturing licenses for local production and certificates of free sale for export as well as licenses to import animal health drug products into Thailand.
Our pharmacists also provide services for animal health drug products at the Thai Customs Department.