Implementation of FDA cGMP/Compliant Quality System
FDA Inspections

  • Pre-inspection readiness
  • War-room handling/support during inspections
  • Form 483 and warning letter response support
  • Regulatory meeting preparation and support

FDA Pre-Approval Inspections (PAI)
Mock Inspections and cGMP/QSR Assessments
Investigation and CAPA System

  • Laboratory, Manufacturing and Complaint support and backlog reduction
  • Retrospective/Prospective review
  • Investigations/complaints handling outsourcing

Human Error Reduction and Prevention Programs
Implementation and enhancement of Quality Risk Management programs
Annual Product Review/Product Quality Review Support and Outsourcing, Including Data Trending and Analysis
Computer System Validation and 21 CFR Part 11
Data Integrity Audit and Assessment, Remediation and Training 
Validation Life Cycle

  • Laboratory Test Methods Development and Transfer (Analytical & Microbiological)/LIMS
  • Facilities/Utilities/Equipment
  • Cleaning
  • Processes
  • Sterilization Methods

Operational support

  • QC Laboratory analysts
  • QA Documentation and Change Control
  • Documentation Simplification
  • Batch Record/Device Record Enhancement
  • Documentation Enhancement
  • Sampling Plans Assessments and Statistical support


Contact Us to Receive a Quote