Compliance and Cost Competitiveness

FDA-US-Agent-and-AdvisorValidation Edge, LLC has a proven track record of creating policies, procedures and templates for the commissioning, qualification & validation protocols and final reports.

We provide support and consultation for the Facility, Utilities and Equipment Qualification, Process Scale-up, Process ValidationCleaning Validation, Computer System Validation, and Process Improvement Projects for the Pharmaceutical, Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredient (API) industries.


"We always focus on providing compliant and cost effective validation services to our clients"


Validation Edge Services

  • Validation Policy & Validation Master Plans
  • Process Scale-up & Process Validation
  • Cleaning Validation & Residue Recovery Studies
  • QbD-aligned PDR/QOS for ANDA Submission
  • Facility, Utilities & Equipment Qualification
  • FDA Inspections; 483’s & Warning Letter Remediation
  • ANDA/CBE-30/PAS Filing 
  • ANDA Deficiencies Response Preparation
  • Compliance Gap Analysis & Remedial Action Plans