Breaking News! TALENT obtained the Pharmaceutical Dealer License
TALENT received permission for the Pharmaceutical Dealer License on November 23, 2023; providing our clients with a more comprehensive service. According to the Taiwan Pharmaceutical Affairs Act, a designated license holder in Taiwan is required for overseas manufacturers to apply for a pharmaceutical license from the Taiwan Food and Drug Administration, and now TALENT could be your designated license holder now.
What is clinical trial monitoring?
The purpose of implementing monitoring during the clinical trial is to ensure quality operation and data as well as trial efficiency. Sponsors should develop a clinical trial monitoring plan based on the benefit and protection of the subjects, along with the accuracy and completeness of the data, to ensure that the trial is conducted under appropriate monitoring. The sponsor would appoint the Clinical Research Associate (CRA) and choose site monitoring, system remote monitoring, or both.
Breaking News! TALENT Recognized as a Pharmaceutical R&D Service Company from the Ministry of Economic Affairs
In light of the rich and versatile experience of TALENT team in clinical fields, TALENT was accredited the certificate of Contract Research Organization by the Ministry of Economic Affairs of Taiwan on October 27, 2023, and was listed on the announcements. TALENT always upholds the principle of offering excellent service to our clients, providing full services from clinical trial design, operation, and management. We provide professional services at all stages of clinical trials, including clinical monitoring, inspection assistance, medical writing, and statistical analysis. TALENT continuously invests in our team's expertise to deliver better quality services. Choosing TALENT as your clinical research partner not only reduces the time and labor of product research and development, you are now applicable for application to the “Investment Tax Credit for Research and Development Expenses of biotechnology and pharmaceutical industries”. This allows for investment tax deductions for our clients, reducing the cost associated with biotechnology and pharmaceutical research and development. For more detail of the regulation, please refer to the link: https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=J0040049
What is ISO and ISO 13485?
ISO is an independent international organization established in 1947 with a membership of 169 national standards bodies. ISO develops and publishes international standards. Until now, ISO has published over 20,000 international standards, covering technology, management, manufacture, etc. Each international standard will be updated and revised according to the current situation, and the year of publication will be added after the name of the guidelines. However, ISO is not responsible for institutional certification which external certification agencies perform.
Requirement of medical device application in Japan
Japan is the world's third-largest medical market due to the high coverage rate of its healthcare system and an aging population, which increases the demand for various medical devices. In recent years, the Japanese government has been gradually simplifying the review process to expedite approvals for medical products and has established a medical information database to improve information disclosure.