Support for Global Application

US, EU, Japan, Australia, Canada, etc.

Completed eCTD Production Line

Consistent word format, convenient PDF document preparation and accurate verification.

Application Document Management

Lifecycle Management of Submission Documents Consistent with ICH EDM Model and eCTD Model.

Application Service

Submission Services in Full Response to eCTD Specifications.

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http://www.esafemedconsult.com/

F7, Building 12, No.2 Kechuang Sixth Street, Beijing Economic and Technological Development Zone, Beijing, China

Contact: Mr. Li

Email: consult@esafemedconsult.com

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About Guoke E-SAFE

Guoke E-SAFE specializes in R&D consulting services for pharmaceutical products, has a rich and complete expert base, and establishes a consulting service platform for the entire chain of pharmaceutical R&D and registration, which can provide customers with consultancy service, from comprehensive R&D strategy formulation, to regulations and information involved in the process of product R&D project, pharmaceutical research, nonclinical study, clinical study, product application for marketing (China-US Application), post-marketing large-scale product cultivation, etc. In addition, Guoke E-SAFE can provide customers with docking to nonclinical and clinical research institutions that comply with GLP and GCP regulations, guided by registration and product marketing, and support the entire lifecycle of the drug. So far, Guoke E-SAFE has completed the R&D and registration consultation services for drugs, medical devices, health food in Japan and Korea, and the application and registration services for R&D of new drugs by multiple pharmaceutical companies in China.