Regulatory Services

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.