Quality Assurance (QA)

Practical QA support that strengthens your operational foundation across clinical, GCP, CMC, data integrity, and vendor oversight. Fractional QA leadership or project-based audits available.

V2 provides SOP development, GCP audits, data integrity assessments, TMF reviews, CMC documentation QA, deviation/CAPA support, and vendor qualification. Our approach is grounded, risk-based, and geared toward inspection readiness without over-engineering.