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 assessments
Investigation and CAPA System

  • Laboratory, Manufacturing and Complaint (including FAR) 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
Quality by Design and Pharmaceutical Development Support 

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 and Enhancement
  • Batch Record Enhancement
  • Sampling Plans Assessments and Statistical support


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