Submissions
Regulatory Affairs
Provides comprehensive regulatory guidance, documentation, and compliance support to ensure the submission/trial protocol meet applicable regulatory requirements throughout their lifecycle.
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Management of clinical trials data and medications, along with the preparation of high-quality scientific documents throughout the study lifecycle. This includes study protocol writing, handling investigational products and study medications, performing pharmacokinetic and statistical analysis, preparation of final study reports and expert reports, and developing study designs.
Provides comprehensive regulatory guidance, documentation, and compliance support to ensure the submission/trial protocol meet applicable regulatory requirements throughout their lifecycle.
The clinical department is responsible for ensuring that the study procedures are in compliance with study protocol, Good Clinical Practice, trial participant safety and regulatory requirements.
Bioanalytical services covering method development, strict regulatory validation, and high-throughput clinical sample analysis to accelerate drug development.