Stock(600222)Hot line:010-61006450


Leader of "0" Cost MAH 3.0 Era

Drug Administration Service

Platform Overview

The drug administration service platform has rich experience in drug administration registration of generic drugs and innovative drugs at home and abroad, has a strong drug administration management team support system and internal and external expert team, which can take the efficient and high-quality listing of products as the end goal, assist enterprises to do a good job in the top-level design, process monitoring and safety declaration and approval of product R&D registration, and realize one-stop full-process registration services.

Service Content

1)Registration-related affairs: the formulation of specific variety registration strategies (feasibility analysis, GAP analysis, technical evaluation), the organization and evaluation of registration application materials, the coordination organization of communication and exchange meetings with regulatory authorities (Class I, Class II, Class III) at all stages of the product life cycle such as IND/NDA/post-marketing, and moving the progress forward of review and approval of each link of registration application;

2)Pharmaceutical administration-related affairs: top-level design system process for projects with registration and application, drug policies and regulations to check and publicize, training work procedures, registration data submission and acceptance management procedures in stages, application materials writing management procedures, process control management procedures of the ministry of drug administration, etc.