Analytical Method Support

Analytical Method Support

Assistance with method development, validation, transfer, and compliance alignment in analytical workflows.

Service Overview

Our analytical method support services provide comprehensive assistance throughout the entire method lifecycle, from initial development to routine implementation. We help laboratories develop robust, validated analytical methods that meet regulatory requirements and deliver reliable results. Our team of experienced analytical chemists works closely with your staff to optimize methods for your specific applications and ensure successful technology transfer.

Key Features
Method development and optimization
Method validation according to ICH guidelines
Method transfer and technology transfer support
Forced degradation and stability studies
Robustness and ruggedness testing
Statistical analysis and method comparison
Regulatory compliance documentation
Troubleshooting and method improvement
Benefits
Faster method development timelines
Improved method robustness and reliability
Regulatory compliance and audit readiness
Reduced method failures and rework
Enhanced analytical confidence and accuracy
Optimized resource utilization
Knowledge transfer and capability building
Risk mitigation in analytical processes
Our Process
1

Method Planning

Collaborative planning session to define method requirements, acceptance criteria, and validation strategy.

2

Development & Optimization

Systematic method development using design of experiments (DoE) and optimization techniques.

3

Validation Execution

Comprehensive method validation following ICH guidelines with statistical analysis and documentation.

4

Implementation Support

Method transfer, training, and ongoing support to ensure successful routine implementation.

Applications
Drug Substance Analysis
Drug Product Testing
Impurity Profiling
Stability Studies
Bioanalytical Methods
Environmental Analysis
Food & Beverage Testing
Raw Material Testing