How We Work

  • Project- Based Consulting

    Support for targeted regulatory, quality, or audit-readiness initiatives.

  • Strategic Advisory

    Ongoing mentoring, training, and roadmap development.

  • Remediation Strategies

    Resolution of regulatory issues, including FDA warning letters, 483s, and compliance gaps, through targeted remediation strategies. 

  • Fractional Leadership Roles

    Interim Head of Quality or Project Leadership Support