Accestra provides broad regulatory affair consultation service for pharmaceuticals and related healthcare products in China. With thorough regulation knowledge and solid registration experiences, we assist our clients successfully move through the regulatory process. All our services are conducted with high efficiency while technical data and confidential business information being strictly protected.
Pharmaceutical Regulatory Advisory
Service Work Flow
Provide the technical support & feasibility assessment before the registration project begins, including the completeness check of the existing technical documents and assist the information supplementary
Prepare and submit the whole registration dossier according to China NMPA’s requirement
Support the sample testing and standard validation work required by China Drug Control Institute
Technical support if production site audit is required
Assist project management if clinical trial in China is required to be conducted
Follow up closely and response timely during the whole registration process
Regulatory consultant service after registration finished