Accurant Biotech

Cranbury,  NJ 
United States


  • Accurant Biotech
    Accurant is a CRO with labs in US China. We provide bioanalysis and CMC testing for all modalities including Gene&Cell therapy. our focus on PK, PD, Immunogenicity, product QC, CDx, regulatory affair and trial support....

  • Accurant Biotech has 3 GLP labs in US and China . 

    Bioanalysis: PK/PD/Immunogencity (ELISA, MSD, Cell-Based Assay, Flow-Cytometry, IHC, PCR, NGS, LC/MS, etc).

    CMC: General and Compendial Testing, Impurities Testing, Potency Testing, Stability, Structural Analysis, Higher Order Structure Analysis, Glycosylation, Pre-Formulation and Formulation Development Support, etc.

    Regulatory Consulting: End to end project life-cycle management, advising on project selection, product milestone setting, and project execution, Pre-submission review and editing of technical documents (QOS, PDR, module 3, etc.), Dossier audit (Module 1 to module 4), Assisting in FDA deficiency letter response (IR, DRL, CR, etc.), Raw material, in-process and finished product specification advising (development, evaluation, review, etc.)