Quality & Compliance

  • Quality Assurance, Auditing, Compliance, Quality Systems and Quality Control

  • GMP/GCP/GVP/GLP

  • Systems Validation & Auditing

  • Inspection Readiness, Hosting & Remediation

  • FDA 483 Response Preparation and Review

  • SOP Development and Review

  • Batch Record Review

  • CAPAs and Quality Management Plans

  • ISO Compliance

  • Document Control

  • Training

  • Validation Guidelines, Validation Plans, Test Plans and Procedures

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Contact Us

(781) 328-1132

300 Unicorn Drive

Woburn, MA 01801

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