1.        Regulatory Affairs Consulting 

To provide regulatory consultation for global customers so as to understand the latest regulatory status and requirements for medicinal products to be marketed in China.

2.        Drug Registration

To provide full-service for drug registration in China.

3.        API Filing

To provide full-service for API Filing in China.

4.        Pharmaceutical Excipients Filing

To provide full-service for Pharmaceutical Excipients Filing in China.

5.        Container Closure System Filing

To provide full-service for Container Closure System Filing in China.

6.        Medical Device Registration

To provide full-service for Container Closure System Filing in China.

7.        Dossier Review

To review the technical documents to help the applicants prepare the dossier as required by China regulation.

8.        Dossier Translation

To translate  the dossier.         

9.        Dossier Preparation and Sorting

To prepare and sort the dossier as required by China regulation.

10.    Dossier Submission

To submit the Registration Application to NMPA for acceptance.

11.    Follow-up and Communication with NMPA

To follow up the review and approval as well as keep good communication with NMPA and applicants.

12.    Legal Agent

To provide the applicant with the identity of the registration agency in China and to perform the relevant duties and obligations.

Our Advantages

1. Effective Communication           Follow up the regulatory changes immediately and keep good communication with NMPA for 20 years

2. Professional and Experienced team   The average working time in R & D and registration is 12 years.

3. High-quality Service              High-quality and efficient services to assure promoting the marketization of products in China.