Drugs Registration

We are familiar with the registration regulations, policies and technical requirements for chemical drugs in China, the United States and the European Union, and can provide domestic and international clients with drug development and registration strategy consultation services, as well as the preparation and submission of dossier on investigational new drug (IND), new drug application (NDA), abbreviated new drug application (ANDA) and imported drug based on NMPA, FDA and EMA.

Service Contents

◆Consulting services: product registration classification, filing or registration process, post approval changes, re-registration procedures, etc.

◆R&D strategy design: provide R&D strategy design and suggestions according to the registration requirements of the target countries for product launch, etc.

◆Writing and filing of submission dossiers: provide services for writing of submission dossiers, review and evaluation of registration dossiers, and filing of registration dossiers, assist customers to communicate with the drug evaluation agencies and prepare related documents, assist and guide customers to response the questions from administrative agencies, etc.