Quality PolicyQuality PolicyBeijing Scinovo Laboratories Ltd has set up the independent quality assurance department, The QA department is staffed by experienced personnel, who account for more than 20% of the total number of employees. About 67% of QA personnel have a master's degree or above in pharmacology or related disciplines. All the QA personnel have received professional training and post training. In order to ensure the quality of research projects, Beijing Scinovo Laboratories has established a scientific, complete and effective quality assurance system in accordance with domestic and international relevant regulations and guidelines , such as China National Medical Products Administration (NMPA), US Food and Drug Administration (FDA), European Drug Administration (EMA) and other national drug regulatory agencies. The quality system covers all the quality elements and processes of laboratory work. System CertificationSystem CertificationScinovo Laboratories has obtained CNAS (ISO 17025) laboratory accreditationFirst recognized in February 2019, re-evaluated and expanded in 2023Scinovo Laboratories has obtained CNAS (ISO 17025) laboratory accreditation/ First recognized in February 2019, re-evaluated and expanded in 2023On July 4, 2023, Scinovo Laboratories passed the re-evaluation and expanded scope evaluation by the China National Accreditation Service for Conformity Assessment. The review panel not only gave high recognition to the existing testing capabilities but also recommended and approved the newly added immunoassay platform and molecular biology platform testing capabilities. This represents a high level of affirmation for the technical proficiency and testing capabilities of Scinovo Laboratories in the fields of mass spectrometry detection, ligand binding assays, and molecular biology. It also signifies that the comprehensive PK/PD platform of Scinovo Laboratories possesses management standards and testing capabilities recognized at both national and international levels. This can provide more robust technical support for preclinical PK/TK studies of chemical and biological drug through to clinical phases of PK/PD, immunogenicity, biomarker/pharmacodynamic marker research, thus safeguarding drug development. Quality StandardQuality StandardScinovo Laboratories operation project meets the following regulatory requirements.Scinovo Laboratories operation project meets the following regulatory requirements./
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