Company Profile
Year Established :
2015
Total Number of Staff :
10-50
Main Competitive Advantages :
International Approvals/Standards,Quality Service
Business Type :
Service Provider
Main Sales Markets :
North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Product Range :
GMP consulting and execution
DMF/CEP/ASMF/WHO PQ/Chinese drug registration
Audit
Foshan RuiTong Consulting Co.,Ltd. (afterwards named as RuiTong) is a GMP con-sulting and execution company located in Foshan City, Guangdong Province, China, its main service contents include GMP consulting and execution, DMF/CEP/ASMF/WHO PQ registration, Audit.
GMP consulting and execution services contain project management, Documentation system establishment, qualification and validation (URS, risk assessment, Design and DQ, IQ, OQ, PQ, computerised system validation, AMV, process validation, cleaning methods validation), training. Provide long-term on-site services until finishing process validation and cleaning methods validation, support to run the whole quality system.
DMF/CEP/ASMF/WHO PQ/ Chinese Drug resitration services contain preparation, delivery of US DMF, EDQM CEP, Europe ASMF, WHO PQ, Chinese drug registation documents, review the compliance of relevant data for drug registration.
Audit services include compliance audit (Gap analysis), supplier audit and audit assistance services (such as mock inspection before officail inspection, on-site translation during official inspection, deficiencies correction after offficial inspection.)