Quality Policy

Quality Policy

    Beijing 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 Certification

System Certification

Scinovo Laboratories has obtained CNAS (ISO 17025) laboratory accreditation

First recognized in February 2019, re-evaluated and expanded in 2023

Scinovo Laboratories has obtained CNAS (ISO 17025) laboratory accreditation

/ First recognized in February 2019, re-evaluated and expanded in 2023

    On 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 Standard

Quality Standard

Scinovo Laboratories operation project meets the following regulatory requirements.

Scinovo Laboratories operation project meets the following regulatory requirements.

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Quality Management Standards for Drug Clinical Trials

Quality Management Standards for Drug Nonclinical Research

Guidelines for the Management of Biological Sample Analysis Laboratory for Drug Clinical Trials (Trial)

Guiding Principles for Validation of Quantitative Analysis Methods of Biological Samples (2015 Chinese Pharmacopoeia)

Requirements for the Application of New Registration Classification of Chemical Drugs (Trial)

Requirements for Pharmaceutical Record Keeping and Data Management (Trial)

Criteria for Accreditation of Testing and Calibration Laboratories

Criteria for the Accreditation of Testing and Calibration Laboratory Competence in the Field of Chemistry

Bioanalytical Method Validation and Study Sample Analysis(M10)

FDA. Guidance for Industry - Bioanalytical Method Validation. 2018.05.
FDA. Guideline on Bioanalytical Method Validation. 2012.02.
FDA. Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry. 2019.01.
FDA. Guidance for Industry-Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. 2016.04.
FDA. Good Laboratory Practice for Nonclinical Laboratory Studies. 21 CFR Part 58.

FDA. Bioanalytical Method Validation for Biomarkers. 2025.01


Good Clinical Laboratory Practice(GCLP)

Principles on Good Laboratory Practice 

Guideline on bioanalytical method validation
Guideline on Immunogenicity assessment of therapeutic proteins
GAMP 5