• Development & Build-Out

  • 503A & 503B build-out, inspection, & permitting

  • Healthcare/Infusion centers, lounges, and mobile service development

  • Quality management platform design, management, and onboarding

  • Design, Workflow & Equipment Planning

  • Staffing Models & Workflow

  • Formulary development

​

• Quality & Regulatory Compliance

  • Audit Readiness

  • Regulatory Inspection responses & remediation activity

  • USP <795>, <797>, and <800> Compliance

  • Personnel development & Training

  • Equipment, Facilities, & Validation Management

    • Instrument Calibration & Maintenance Schedules

  • Quality management system platform oversight

  • SOP Development & Periodic reviews

  • Formulary development & support

  • Supplier Quality management

  • Mock Audits

  • Regulatory licensing/permitting

​

​​