KriSan Biotech

KriSan Biotech has established an independent Quality Management (QM) team to build up a quality system that complied with FDA. This is to ensure the manufacturing activities performed at KriSan Biotech are under CGMP manners. Dedicated QM team is assigned to ensure all documentation and records, SOP's and laboratory controls are well maintained. This group is also responsible for internal audit, reviewing batch record preparation and execution as well as analytical support. The QM team also works closely with customer to facilitate site audits, implement special requests and manage any GMP issues that arise during the manufacturing progress. Listing below is the typical quality system established at KriSan Biotech: • Standard Operating Procedures • Good Documentation Practice • Vendor qualification • Quality incident management • Change control • Calibration and maintenance • Validation and qualification management • Package and label management • Internal audit and routine inspection • Management of employee training, archive, material, specification and etc. Listing below is the typical regulatory services we provide: • Regulatory and strategic consultation for early development stage of new drug • Compiling of registration materials, including reviews, CMC, Pharmacological and toxicological data and clinical research protocol • Preparation of registration documentary • Submission of registrati on materials, coordinating and preparing for the On-site inspection • Compiling Drug Master File (DMF)