Medicine registration in China

We can supply the following service of import registration for medicine related:

lChina mainland market research and feasibility assessment of registration;

lThe gap analysis for the registration documents;

lFiling and submitting for the registration documents;

lCommunicating with the CDE of the State Food and Drug Administration for foreign enterprises on import registration regulatory affairs;

lResponsible for the entire life cycle of the product,tracking the registration progress from the submission of materials, communicating with reviewers, providing feedback to the company and customers and providing solutions;

lPharmacovigilance system related services.

lRegistration for Import/domestic API, pharmaceutical excipients and package material;

lRegistration and technical maintenance for Import/domestic formulation;

lRegistration and technical maintenance for Import/domestic veterinary drug;

lRegistration and technical maintenance for Import/domestic medical device.

International registration of Drug

lFeasibility assessment and registration plan for international market registration;

lCompile the eCTD format of DMF files for the API, pharmaceutical excipients and packaging materials;

lCompile eCTD dossiers for preparation products;

lResponsible for the entire life cycle of the product from registration to post-market maintenance;

lAssist domestic enterprises to communicate with pharmaceutical authorities in Europe, the United States, Canada, South Korea, Japan, Mexico, Brazil, the United Kingdom and other countries and regions;

lPharmacovigilance related services.

lRegistration and technical maintenance of US DMF for API, pharmaceutical excipients and packaging materials;

lRegistration and technical maintenance of US ANDAs;

lFacility registration, self-identification and NDC application in US FDA;

lCEP/ASMF application and technical maintenance;

lAPI registration and technical maintenance in India, Japan, Korea, Mexico, Brazil, middle east and southeast Asia;

lRegistration of traditional Chinese medicine in Vietnam and Singapore,;

lRegistration of chemical drugs in Southeast Asia, South America and Africa.

GMP compliance services

Scope of service:

lThird party GMP audit and consultation service;

lThe team of audit experts has more than 10 years of management and audit experience in the pharmaceutical and chemical industries. Provide          Pre-audit services for factory that is about to be inspected by the European member states or US FDA;

lAssist the pharmaceutical enterprise to prepare NMPA/FDA/EUGMP/PMDA/ MFDS/COFEPRIS inspection (including mock inspections);

lGMP audit, provide on-site technical guidance and assist pharmaceutical enterprise to correct and prevent inspection defects (CAPA);

lSupplier qualification audit.

Medical Translation (English/Japanese/Russian/Spanish/Korean)

lTranslation of GMP inspection related document

lTranslation of registration documents and literature

lTranslation of overseas supplier audit, project cooperation negotiation, etc.;

lOn-site audit translation for pharmaceutical enterprise

lTranslation of online conference and GMP audit

lTranslation of FDA, EU GMP inspection and other on-site GMP

lTranslation of GMP inspection report and CAPA