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 for PMA
Mock Inspections and QSR Assessments
Investigation and CAPA System

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

Human Error Reduction and Prevention Programs
Implementation and enhancement of Risk Management programs
Design Control
Computer System Validation and 21 CFR Part 11
Data Integrity audit and Assessments, Remediation and Training 
Validation Life Cycle

  • Laboratory Test Methods development and validation / LIMS
  • Facilities/Utilities/Equipment
  • Cleaning
  • Processes
  • Sterilization methods

Operational Support

  • QA Documentation and Change Control
  • Documentation Simplification and Enhancement
  • Device Record Enhancement
  • Sampling Plans Assessments and Statistical support


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