We provide professional gap analysis and simulation audit services for chemicals, biologics, and packaging products to help pharmaceutical companies and pharmaceutical companies improve their quality systems. During the mock audit process, our rich practical experience enables Tigermed to accurately grasp the key points of the audit and to maintain effective communication with our clients from multiple levels and aspects, such as procedural requirements, regulatory requirements, and technical compliance, in accordance with China GMP, US cGMP, and EU GMP regulations, as well as with reference to official inspection features, relevant industry guidelines, and our practical experience in on-site inspections, to ensure Rapid progress of the project and continuous tracking. Provide targeted solutions to the problems found and conduct acceptance.
We have served gap analysis and simulation audit of multiple APIs, preparations, and biological products projects, including drug production sites, Quality System, laboratories, new production plants and related system file improvement, data integrity improvement, etc., and issue relevant gap analysis and simulation audit report, provide solutions to the problems found, and conduct acceptance.
As a subsidiary of Tigermed, we have a strong background and work with Tigermed Group and other sister companies to provide a one-stop service platform for domestic and international clients from R&D, registration, and transformation to production.
Over the last two decades, Canny has formed a mature and standardized service system in terms of consultant team, service standards, service protocols, project management and confidentiality system, and has passed ISO 9001 quality management system certification for many years, providing professional services to more than 1370 Chinese and foreign clients in total.
practices in pharmaceutical industry
Global clients and partners
Global GMP inspection & certification projects
We always have a good communication with authorities, closely follow-up the updated industry trends, and establish a fully-fledged information and documents database, which enable us to have strong information integrating and analyzing capabilities so as to share with our clients and support them from R&D system establishment, clinical trials operation, RA, GMP compliance and MAH related support.