Henogen's Service Offer: From gene to patientQuality Assurance and Regulatory AffairsHenogen's QA team is responsible of the application of GLP, GMP and GCP requirements concerning development, manufacturing and clinical validation of investigational medicinal products. The application of these requirements is intended to ensure that trial subjects are not placed at risk, and that the results of clinical trials are unaffected by, inadequate safety, quality or efficacy arising from unsatisfactory manufacture. The team has the following responsibilities : regulatory affairs, validation of procedures and processes, evaluation of batch records and release of clinical lots by an industry pharmacist, biosafety aspects, personnel training, self inspections, approval and monitoring of suppliers, data management, co-operation with trial sponsors, preparation of submission files... In addition, Henogen’s QA team provides assistance to customers for quality management and regulatory affairs.The team, in addition, provides assistance to customers for standard operating procedures and regulatory affairs. Finally, Henogen’s clinical unit supervises clinical trials up to phase III.Good Manufacturing Practice Certificates |