Consulting & Filing

Providing immediate, accurate and diversified regulatory consulting services, from clinical trial application to license issuance, we give the clients the correct direction and strategy for product development. Due to accumulated experience, we can communicate with regulatory authorities well to shorten and accelerate the process. In response to the needs of clients’ global layout, we integrate the regulatory requirements of multiple countries and propose effective plans. Currently, the services are mainly based on the United States, Taiwan, China and other English-speaking countries.

• Consultation with Regulatory Authority

• Documents Preparation, Editing, Submission and Review Management

• Clinical trial (for health authority and IRB/IEC)

• Investigational New Drug (IND) (CTD, eCTD, traditional)

• New Drug Application (NDA) (CTD, eCTD)

• API Master File

• Plant Master File (PMF)

• Bridging Study Evaluation Report

• Clinical Trial Interim Report