Failure Analysis
Root Cause Failure Analysis
Expert investigation of product failures. Identify failure mechanisms, degradation pathways, and contamination sources with systematic, data-driven analysis.
Systematic Investigation
Advanced Analytics
Data-Driven
Prevention Focus
Program Highlights
- Rapid-response investigations for critical events
- Multi-technique impurity and contamination analysis
- Degradation pathway and stability failure mapping
- Corrective action recommendations with reports
Critical
Rapid-response support
Root Cause
Evidence-driven conclusions
Prevent
Corrective action focus
How We Work
From Request to Report in 3 Steps
1
Scope & Method Fit
We review your analytes, matrix, and specs to confirm the right method and timeline.
2
Run & Validate
Testing is executed with system suitability, QC checks, and documented traceability.
3
Report & Support
You receive a clean data package, summary, and follow-up support as needed.
Standards & Certifications
GLP
cGMP
21 CFR Part 11
OPPTS 830
USP-NF
OECD
CIPAC
ISO 17025
Failure Investigation Services
Systematic analysis to identify and prevent product failures
Product Recall Investigation Critical
- Rapid-response investigation for recalled products
- Comprehensive chemical profiling of affected batches
- Root cause determination with regulatory-ready reports
- Corrective action recommendations
Contamination Analysis
- Contaminant identification and source determination
- Cross-contamination pathway investigation
- Trace-level foreign substance detection
- Environmental and process contamination assessment
Efficacy Loss
- Active ingredient degradation profiling
- Potency loss mechanism identification
- Environmental exposure impact analysis
- Formulation-related efficacy changes
Manufacturing Quality
- Batch-to-batch variability investigation
- Process deviation impact assessment
- Raw material quality-related failures
- Equipment and process optimization data
Storage & Stability
- Accelerated aging failure investigation
- Temperature/humidity excursion impact analysis
- Packaging compatibility assessment
- Shelf-life failure mechanism determination
Customer Complaint
- Field complaint investigation and analysis
- End-user reported issue verification
- Comparative testing of complaint vs. retained samples
- Documented findings for customer response
Ready to get started?
Tell us the issue and timeline. We will map the fastest path to root cause.