We have a global team of experts in the Americas, Europe, and the Asia-Pacific region to help customers understand and comply with regulatory requirements in these regions, and market their products from a regulatory perspective. The Regulatory Affairs Department also assists in developing strategies, clinical trial planning, and regulatory documents submitting.
Experience of ClinChoice Japan so far:
- By working closely with ClinChoice China, we are able to provide China-related services in Japanese.
- Provide translation of application-related documents for authorized partners (Japanese → English, Chinese).
- Provide medical affairs consulting (one-time contract or annual consulting contract).
- Write the main medical-related documents for drug application.
- Write clinical development plans.
- Write clinical trial protocols and related documents.
- Provide clinical trial medical monitoring.
- Provide consulting on the following applications on behalf of Chinese authorities:
- Drug Master File (DMF) applications.
- Research the market share of similar drugs in China and the likelihood of successful applications.
- Translate the GB and YBB standards in China (Chinese → Japanese).
- Research the feasibility on chemical imports.
- Organize medical trend seminars on specific topics.
- Prepare publicity advertisement for clinical trials on the Chinese market