Beijing King Rabroad Consulting Inc. (KRB Consulting)

Beijing King Rabroad Consulting Inc. (KRB Consulting) is a Chinese consultancy engaged in regulatory compliance consultation for the pharma industry. We focus on providing regulatory affairs services, GMP compliance (GxP compliance), QMS digitization, and related services for the pharma industry around the globe. Our goal is to help pharma companies pass the registration and GMP inspections in the target country/region, so as to achieve market access in this country/region. At the same time, our business also covers related preparation work required to achieve the target, such as factory design review, quality system establishment, training analysis, registration dossier compilation, training, validation and qualification testing, translation, official GMP inspection assistance, CAPA response and other related work. Our consulting work is divided into two main directions: Direction 1: Help Chinese pharma companies register their products with NMPA, FDA, EU authorities (EMA/member states), MHRA, EDQM, PMDA, TGA, WHO, PIC/s and other relevant authorities, and pass relevant GMP inspections, so as to achieve market access in these countries/regions. Direction 2: Help overseas pharma companies to register their products with CDE, and pass the GMP inspection conducted by CFDI, so as to achieve access to the Chinese market. Our experience In the past 10 years, we have helped hundreds of FDF and API companies in China achieve registration or GMP clearance in developed/regulated countries, helping them achieve compliance with international laws and regulations. At the same time, we have helped more than 20 overseas companies to achieve registration and GMP clearance with NMPA, so as to achieve access to the China market.