Specialization · GxP

Quality & Compliance

QA, regulatory remediation, deviation management, and audit readiness for FDA / EMA / Health Canada sites.

Core Capabilities

What our placed engineers do daily.

  • Tier 1–2 deviation investigations and OOS event leadership
  • CAPA authorship, effectiveness checks, and trending
  • Post-warning-letter remediation and consent-decree support
  • Veeva Vault QualityDocs, TrackWise, MasterControl
  • Internal, supplier, and regulatory audit hosting
  • Annual Product Review (APR) and Product Quality Review (PQR)
FAQ

Frequently Asked Questions

We place Quality Engineers, Quality Assurance Specialists, CAPAs Specialists, Auditors (internal and supplier), Document Control Associates, and QA Managers across pharmaceutical and medical device companies in the NY/NJ region.