Customize Your Clinical Study Protocol
Contact Customization
97%97%
100%100%
100%100%
Construction of registration strategies for innovative drugs, modified new drugs and generic drugs;
CMC, non-clinical in-depth GAP analysis and solutions;
Review and writing of IND, NDA, BLA and ANDA application materials;
Writing of materials for re-registration and supplementary application for post-marketing drug products and materials for OTC conversion;
Submission and follow-up of application materials, communication with regulatory authorities with high efficiency;
Preparation, validation and submission of eCTD application.
Registration strategies, clinical path and clinical evaluation strategies;
Application for category definition of new products and property definition of drug-device combination products;
Document preparation and submission for initial, extended and changed registration, and responses to supplementary comments from the review center;
Support registration type testing, supplementary testing and ISO standard testing;
Support application for innovative medical devices.
HGRA application (100% pass rate in recent four years);
Registration of drug clinical trials;
Application for medical device clinical trials;
Filing of drug/device clinical trials in provincial authorities;
Regulatory support in drug clinical trials.
