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

Mock Inspections and cGMP 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 Preventive Controls and Risk Management programs
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\
  • Sampling Plans Assessments and Statistical support


Contact Us to Receive a Quote