CSR specializes in Supplier Quality Assurance services for the Greater China Region. It can assist Supplier Quality Assurance to meet U.S. pharmaceutical standards and comply with U.S. Food and Drug Administration (FDA) requirements through many and diverse services, including the following programs that may take place at the supplier sites: GXP/GMP compliance monitoring program; GXP/GMP standards SOP development program; Quality System and other FDA Inspection Systems improvement program; Development of Validation program.

 

Over 100 years of combined experience with the U.S. Food and Drug Administration (FDA) includes interactions at the Centers in Washington, D.C., and the District Offices in the field, for product development at the IND phases and the pre-NDA stage with final product marketing authorization, for chemical and biotech products, for human and animal health products, for drugs and medical food products.

 

CSR offers training programs that include Quality/Compliance and Regulatory Workshops at its Training Center in Shanghai, China. It can offer similar training services at the supplier/vendor sites. Its training programs are conducted in the language of the markets it serves. Its Workshops can assist in preparation for the U.S. professional certification exams.

 

Its management team is comprised of US-trained pharmaceutical professionals with impeccable scientific training, global business know-how and substantial experience with major regulatory authorities.