Analytical & Investigative Services for Failure Analysis

Failure Analysis

Gateway Analytical is a full service cGMP compliant, FDA registered and inspected laboratory, that offers a unique forensic-based methods for failure analysis. Stemming from 18 years of experience in pharmaceutical testing, forensic investigation and materials analysis, our method allows us to not only quickly identify the root cause of product failures, but also answer the who, what, when, how and why of the investigation process.

This method, coupled with state-of-the-art analytical instrumentation allows us to solve many commonly encountered problems such as issues arising from delamination and packaging failures, defects occurring from mechanical or equipment failure, to even polymorphs arising in pharmaceutical products. Understanding that time is of the essence, we work quickly and diligently with our customers to pinpoint the cause of failures and provide solutions to improve overall process development and quality control, often in days not weeks.

  • Failure and Root Cause Analysis
  • Nonconformance Issues
  • OOS Investigations
  • Raw Materials Analysis
  • Product Returns or Defect Analysis
  • Product Packaging or Defect Analysis
  • Counterfeit Drug Investigation
  • Adhesion and De-lamination Analysis
  • Mechanical & Equipment Failures
  • Thermal or Mechanical Glass Failures
  • Particle Contamination Characterization
  • Contamination Source Determination
  • Foreign Particulate Matter Identification
  • FDA Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions
  • Support of patent infringement litigation
  • Method development and validation protocol
  • Support and guidance for companies going through bioequivalence

Request a Service

Gateway Analytical works closely with our customers to provide accurate, time efficient services, every time. If you are interested in our failure analysis services, please contact us by filling out the short form.