Why ClinChoice for Regulatory Affairs
With over 25 years of experience, ClinChoice Group’s regulatory services have submitted 37 products and 178 items to the FDA, all of which have been accepted. Our global team of experts across the Americas, Europe, and Asia/Pacific regions helps clients understand and comply with regional regulatory requirements to market their products. The regulatory services division also assists in developing strategies, planning clinical trials, and preparing submission documents.
Experience of the ClinChoice Japan
Collaborating closely with the ClinChoice China, we provide below services in Japanese:
- Translation of submission documents (Japanese to English, Chinese)
- Regulatory consulting (from single sessions to annual contracts)
- Agency services for Chinese regulatory submissions
- Drug Master File applications
- Market share and application success probability surveys in China
- Translation of Chinese GB and YBB standards (Chinese to Japanese)
- Import feasibility studies for chemicals
- Hosting seminars on regulatory trends for specific topics
- Creating clinical trial promotion ads for Chinese participants