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REGULATORY COMPLIANCE SERVICE

We are committed to providing one stop auditing and regulatory solutions to pharmaceutical and food industries worldwide. Our international regulatory team is prepared to provide our customers with supplier quality management services to achieve a high standard of our industry.


We offer global, customized, managed drug /food supplier audit, supplier qualification, official certification and registration services. So far, we have established cooperation with many multinational companies worldwide, such as Bimeda, Ourofino, Interchemie, Delpharm, Evultis etc.


Meanwhile, we have helped many pharmaceutical manufacturers to improve their quality management system. We take pride in navigating with our contract manufacturers for successful FDA/EU approvals and customer audits, such as NCPC, CSPC, Chongqing Southwest No.2 Factory, Zhejiang Xinmingzhu Pharma, Renfu Group Yichang Sanxia Pharma, Livzon Group, etc.

THIRD PARTY AUDIT AND
CERTIFICATION SERVICES

  • ● cGMP / EHS audit: customized supplier audit, CAPA establishment and tracking, GMP improvement.
  • ● NMPA /FDA / EDQM / EU GMP / USP / WHO / other market certification services: GMP gap analysis, mock audit, technical support of site inspection, FDA Warning Letter and Import Alert relieving.
  • ● Oral and written English translation services for official inspection and customer audit.

REGULATORY SERVICES

  • ● DMF / VMF / CEP / ASMF/ TPMF filing: compiling and review, eCTD / eSubmitter conversion and ESG / CESP submission, deficiency letter response.
  • ● U.S. FDA electronic registration: Drug/medical device establishment registration and listing, self-identification, food facility registration, cosmetics registration.
  • ● U.S. agent service.
  • ● Imported and domestically produced API and FDF Registration in China.
  • ● Customized regulatory services for other countries.

Some Successful Cases

Yichang Sanxia Pharma passed U.S. FDA re-inspection under our guidance in Sep. 2023.
Hebei Bimeda passed MCAZ inspection under our support in Nov. 2023.
Hebei Bimeda passed APVMA re-inspection under our support in May 2023.
CSPC Zhongnuo passed EU GMP inspection under our support in Sep. & Dec. 2022.
Zhejiang Xinmingzhu Pharma passed Korea GMP (MFDS) inspection under our guidance in 2019.
Action Labs passed FDA food facility inspection under our guidance in Dec. 2019 and Jul. 2021.
NCPC Aino passed U.S. FDA inspection under our guidance in 2016 and 2019.
Hubei Yitai passed FDA inspection and desk-inspection with our support in 2016, 2020 and 2021.