Regulatory Affairs

• SAFE regulatory services will work with, or function as, your Head of Regulatory to prepare and submit Investigational New Drug (IND) regulatory filings to the China NMPA. 

• We personalize our services for each client based upon your products and internal capabilities.

• SAFE has expertise with all aspects of NMPA IND filing requirements. Our IND consulting services include meeting with the NMPA to gain input and concurrence with IND filing strategies, a critical step for reducing time and costs. We will also ensure that you have the required preclinical data and manufacturing information for your IND filing.

• For more information about our IND Filing services, please contact us.