We introduce the abroad products with advantages to China according to relative laws of National Medical Products Administration (NMPA), transact the marketing authorization certificate in China and sale the imported products to domestic hospitals, pharmacies and manufacturers.
We have professional registration team mastering well relative registration laws to provide practicable and feasible registration service for drugs, medical apparatus and instruments, health food and cosmetic. We, with abundant practice experience, can fully understand the key points of registrated products and detail requirements of registration documentation required by various public authorities and proceed effective communication with customers and pharmaceutical administration department to ensure quick and smooth proceeding for projects.
We do evaluation and risk prediction for the feasibility of drug registration (including subsequent laws, regulations and policies).
We formulate the outline for declared documentation according to CTD format.
We proceed the review, translation, formulation, organization, and verification against the registrated documentation, and submit them to CDE.
According to requirements of NIFDC, we provide the registrated samples for inspection, submit the application and follow the schedule.
We proceed the whole track to the schedule of registration application, the formulation of supplementary solution and datum, the submit of datum.
New Drug Registration: clinical implementation solution integrating laws and clinic.
Bioequivalence: formulate accurate BE solution with high efficiency and meeting registration requirements under the guidance of latest technical specification.
Clinical Test: Phase I to Phase IV clinical tests are the accurate clinic test solution with high efficiency to verificate the safety and effectiveness of drugs.