Quality means something different to all organizations and we work with clients to make the most phase appropriate decisions while keeping the patient in mind.

  • Quality Operations

    Quality Assurance and Quality Control
    CMO/CDMO Oversight
    Batch Record Review
    QC Stability Program
    Data Review
    Method/Process Development
    API/Cell Therapy/Gene Therapy
    Tech Transfer
    Inspection Readiness

  • Quality Systems & Compliance

    Quality Management Systems (QMS)
    Process and Procedure Development
    Electronic Systems (eQMS)
    CAPA/Deviation/Change Control
    Quality Investigations
    Risk Assessment
    Implementations
    Remediations

  • Auditing

    Good Manufacturing Practice (GMP)
    Good Clinical Practice (GCP)
    Good Laboratory Practice (GLP)
    Good Documentation Practice (GDP)
    Good Pharmacovigilance Practice (GVP)
    Bioresearch Monitoring (BIMO)
    Mock Pre-Approval Inspection (PAI)
    EX-FDA