TriApex has a professional regulatory affairs team providing domestic and global regulatory affairs services. The core team members come from well-known pharmaceutical companies and domestic and global regulatory authorities and have 30-year experience in regulatory affairs. We can work with the sponsors to accelerate drug R&D and registration based on regulations and product characteristics.
Service CapacitiesRegulatory support and consultancy
Regulatory strategy and design
Gap analysis
Product development design
Preparation and review of submission dossier
Preparation or review of IND/NDA/BLA/ANDA submission dossier
Preparation or review of various meeting materials
Preparation or review of annual report/DSUR
Preparation or review of changes/supplements in different research stages
Processing of eCTD/electronic submission dossier
Other regulatory affairs service
Program evaluation
Communication with supervision authorities during drug R&D and registration.
Relevant work in drug development, production and clinical inspection.
Handling of administrative licenses
Project ExperienceTraiApex has experience in registration application of hundreds of registrations and communication for over 500 drugs and enabled numerous drugs into the pivotal trial. TraiApex also has led and participated in the marketing authorization of over 200 products.
Official WeChat account
Official video account
Regulatory Policies
Project Management
Global
