TFDA ｜AMSI
Good products should be
released into the world at
the right times
We have successfully completed inspection and registration of products in more than 20 countries. We sincerely look forward to leveraging these experiences to provide you with inspection, registration, and professional consultation services for pharmaceuticals, medical devices, cosmetics, and foods in various countries.
Our Services
TFDA ｜AMSI
Asia Medical Affairs Solutions Inc. provides services to assist you in implementing all registration procedures required by the Ministry of Health and Welfare, including inspections, registrations, and other applications for pharmaceuticals, medical devices, cosmetics, and foods. Asia Medical Affairs Solutions Inc. also offers consultation services and solutions.
Pharmaceuticals
Registration of New Drug (NDA & NCE), Orphan Drug, Generic Drug, Drug Substance (Raw Material), Drug Master File (DMF), Bridging Study Evaluation (BSE), Bioavailability (BA), Bioequivalency (BE), PIC/S GMP, Plant Master File (PMF), Special Import, and Advertisement
Cosmetics
Registration of New Medicated Cosmetics, General Medicated Cosmetics, Formula Reviewing, Package Reviewing, Advertisement, and Test/Assay for Registration
Medical Device
Registration of New Medical Device, In Vitro Diagnostic Devices (IVD), Class I Medical Device, Class II Medical Device, Class III Medical Device, Quality System Documentation (QSD), and Advertisement
Food
Registration of Health Food, Imported Food in Tablet or Capsule Form (Dietary Supplement), Food additive, Genetically Modified Food, Special Dietary Food, Vitamin Supplement, Vacuum-Packed Ready-to-Eat Soy Bean Food, Formula Reviewing, and Package Reviewing
About Us
Asia Medical Affairs Solutions Inc. was established in 2002. For the last 20 years, as one of the few medical and pharmaceutical consultation companies with multiple specializations, we have assisted innumerable products in their successful entry into the greater Asian market. We have successfully completed inspection and registration of products in more than 20 countries. We sincerely look forward to leveraging these experiences to provide you with inspection, registration, and professional consultation services for pharmaceuticals, medical devices, cosmetics, and foods in various countries.
Our achievements
Why People Trust Us
Why choose AMSI?
Asia Medical Affairs Solutions Inc. was established in 2002. For the last 20 years, as one of the few medical and pharmaceutical consultation companies with multiple specializations, we have assisted innumerable products in their successful entry into the greater Asian market. We have successfully completed inspection and registration of products in more than 20 countries. We sincerely look forward to leveraging these experiences to provide you with inspection, registration, and professional consultation services for pharmaceuticals, medical devices, cosmetics, and foods in various countries.
For many years, confidentiality has been the most important principle strictly followed by Asia Medical Affairs Solutions. In doing so, Asia Medical Affairs Solutions has received extremely high acclaim and many accolades from the industry. With good faith, we sincerely ask you to allow us to help you in resolving various regulatory matters and obtaining permits to sell products on the market, thereby enabling you to cast products into the market without lingering worries. In this way, good products may be released into the world at the right times.
Our practical experience dealing with products in many countries.
Asia Medical Affairs Solutions Inc. was established in 2002. For over ten years, we have assisted innumerable products in their successful entry into the greater Asian market.
Our compliance with the principle of absolute confidentiality.
The principle of confidentiality is the highest principle that AMSI strictly abide by, and it has been highly praised and affirmed by the industry.