Domestic / international therapeutic materials registration

New drug certificate

New therapeutic material clinical research registration (IND) service platform

Ganglu clinical registration (IND) application service platform has in-depth understanding of the regulatory and policies of China and the United States as well as its technical requirements for chemical therapeutic materials, and can provide CFDA IND application and USFDA IND /ANDA application services for domestic customers, and CFDA IND/ANDA application services for foreign customers.

This platform serve not only clients who do a complete set of preclinical studies in the company, but also pharmaceutical peers who have separate clinical registration requirements.

Clinical registration services

    Preparation and submission of CFDA IND documents for domestic customers;

    Act as an agent for domestic customers to submit US FDA IND/ANDA documents;

    Act as an agent for foreign customers to submit CFDA IND/ANDA documents;

    Provide project management services (limited to clients with research services provided by Autat).

    Review, organize and evaluate the IND/ANDA application documents provided by customers, and then complete the preparation, review, editing and finalization;

    Before the submission of the application materials: the registration department of Autat will organize an internal technical communication meeting to conduct a detailed analysis of the application projects; after the submission of the application materials, a senior person in charge of the application will continue to communicate with the regulatory authorities to follow up the progress of the application in real time until the successful completion of the application.

Advantages of clinical registration application

With professional IND AND ANDA research teams, we can provide one-stop research, whole process project management and application services;

We have rich CFDA and FDA review expert resources, which can provide tailored, technical, regulatory and application strategy advice.

Our clinical registration and application service platforms can offer practical registration strategies for customers, avoid potential registration risks, ensure timely and accurate submission of application materials, track the progress of review, so as to help customers quickly complete the registration review process.