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