Services

Quality Management System

Gap Analysis
SOP Development
QMS Design/Redesign
Quality Manual
CAPA System
Risk Management

Auditing

Investigator Site
CRO
Internal Process
Computer System
Vendor
Documents
Data

Inspection Readiness

Inspection Preparation
Mock Inspection
Inspection Plan
Risk Assessments

Training

ICH and FDA GCP
Regulatory Inspections
CAPA