Foshan RuiTong Consulting Co.,Ltd. (afterwards abbreviated as RuiTong) is a professional technology service company providing GMP consultancy and execution, drug registration (DMF, CEP, WHO PQ, Chinese drug registration, etc.) , audit services to pharmaceutical enterprises. RuiTong supports Henan Topfond Sci-tech Co.,Ltd. (afterwards abbreviated as Topfond Sci-Tech) to prepare for US FDA on-site inspection since September 30, 2024. Under the comprehensive guidance from RuiTong, RuiTong supports Topfond Sci-Tech to identify risks and prevent risks and improves relevant deficiencies to ensure quality system of Topfond Sci-Tech complies with requirements of GMP and cGMP.

The Simvastatin API and quality system of Topfond Sci-Tech were inspected by US FDA investigator Ms. Janet Rajan on November 18-22, 2024 and finally passed US FDA on-site inspection with two deficiencies, RuiTong had supported Topfond Sci-Tech to submit the responses to FDA 483 observations to FDA on November 29, 2024. During wrap up meeting, US FDA investigator Ms. Janet Rajan fully affirmed the compliance of quality system of Topfond Sci-Tech.

Topfond Sci-Tech had passed US FDA on-site inspection again in November, 2024 after passing US FDA on-site inspection with zero deficiency in August, 2023, which proves that the quality system of Topfond Sci-Tech fully complied with the requirements of cGMP of US FDA, and which proves that GMP consultancy and execution of RuiTong achieves the requirements of cGMP of US FDA. Topfond Sci-Tech passed US FDA on-site inspection once again, which will vastly improve the domestic and abroad status and market competitiveness in medicinal industry.

RuiTong throughout insists vision with “Customer Focus, Result oriented” and helps customer to realize their predetermined goals. If you need to learn more about our GMP consultancy and execution services, drug registration (DMF, CEP, WHO PQ, Chinese drug registration, etc.) services, audit services, please contact us promptly.

Foshan RuiTong Consulting Co.,Ltd.

Room 803, Fuwei Building, Huangqi, GuangFo Road No.1, Nanhai District, Foshan City, Guangdong Province, China

Website: http://www.gdruitong.cn/

Tel.: +86-13660057841, +86-13695153512