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  • Accompanying Audit Translation
  • API Registration

SERVICE

SERVICE DESCRIPTION

Korea MFDS accompanied audit, Japan PMDA accompanied audit

Advantages Introduction

INTRODUCTION OF ADVANTAGES

Autran Biotech has a professional jury team for language translation between China, Japan, and South Korea. The team is equipped with specialized personnel who graduated from a pharmaceutical university and are proficient in the GMP system and ICH Guidelines. Can meet the registration and audit needs of customers in fields such as medicine, biology, and plant extraction. So far, we have provided clients with over a hundred accompanying audits of MFDS in South Korea and PMDA in Japan, as well as over a hundred accompanying audits of Japanese and Korean clients. We have received unanimous recognition from our clients and have reached long-term cooperation agreements.

Outstanding Advantage

OUTSTANDING ADVANTAGES

The jury team has rich domestic and international experience, is proficient in the GMP system, is familiar with the ICH Guidelines, and has a deep understanding of the MFDS audit system in South Korea. It can provide professional and high-quality pre audit services for domestic factories and suppliers

The jury team is proficient in the three languages of China, Japan, and South Korea, while possessing solid industry theoretical knowledge and rich audit translation experience, which can meet the registration and audit needs of customers in fields such as medicine, biology, and plant extraction.

The team is equipped with multilingual translators with professional skills, such as Japanese master graduates, Korean senior simultaneous interpreting interpreters, and can undertake the translation of Chinese, Japanese, and Korean documents of various pharmaceutical related patents and registration documents.

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