Regulatory Services

• Prepare IND and NDA dossiers for regulatory registrations in China or in the U.S.
• Prepare FDA IND or NDA annual reports.
• Prepare Company Core Data Sheets.
• Prepare drug labeling (in Enligh or in Chinese).
• Format and QC regulatory documents.
• Provide quick and affordable translation services for regulatory documents from English to Chinese or Chinese to English.

Contract R&D Outsourcing Services 

We can help you select outsourcing partners to provide affordable services in:

• Setting up in vitro enzymatic, antibody, or cell culture-based assays for drug discovery.
• Setting up in vitro genotypic and phenotypic diagnostic testings for clinical samples.
• Conducting clinical studies.
• Manufacturing APIs
• Developing clinical and commercial drug formulations.