WuXi ATU technical platform based technology and standard submission package services efficiently meet your requirements and help customers to control cost.
We have successfully assisted in obtaining China IND for diversified customer projects since 2017.
The experienced team assist clients to monitor, analyze and feed back regulatory and compliance dynamically, and provide related consulting services to customers.
WuXi ATU provide Pre-IND, IND, BLA, supplementary CMC document preparation services for regulatory compliance to China, the United States, Europe and other countries in terms of customer needs, and also assist in document submission.
The professional team tailor appropriate declaration strategies for customer products and avoid risks while saving time and cost.
Provide product life cycle consulting services and support that meet the requirements of policies and regulations.
Communicate with industry experts and regulatory authorities to deal with the problems in the registration process for customers, evaluate registration feasibility and assist in responding to the registration issues raised by the authorities.