From concept to validated method - expert guidance for robust analytical procedures.
Consultation & Requirements Definition
Initial discovery phase to understand your analytical challenges:
Target analytes and concentration ranges
Sample matrix complexity and interferences
Regulatory framework requirements (USP, EP, ICH, pharmacopeial)
Instrumentation availability and capabilities
Throughput requirements and turnaround times
Data quality objectives and acceptance criteria
Method Design & Optimization
Systematic development using Quality by Design (QbD) principles and Design of Experiments (DoE):
Column/solvent screening and selection
Gradient optimization for resolution and speed
Mass spectrometry parameter tuning
Sample preparation optimization (extraction, cleanup, concentration)
Detector optimization for sensitivity and selectivity
Robustness testing to identify critical parameters
Validation Protocol Development and Method Transfers
Comprehensive validation package ready for regulatory submission:
Validation protocol development with predefined acceptance criteria
Protocol execution with complete data package
Statistical analysis and report generation
Transfer protocol for multi-site or multi-instrument deployment
Comparative testing reports and equivalency statements
Troubleshooting guides and system suitability criteria
Implementation & Training
Hands-on implementation at your facility:
SOP development and documentation
Operator training and competency assessment
System suitability testing implementation
Initial verification runs with your samples
Data review and interpretation training
Change control implementation
Ongoing Support & Optimization
Continuous improvement services:
Method performance monitoring and trending
Troubleshooting support for method-related issues
Updates for new regulations or compendial changes
Technology upgrade integration and re-validation
Method improvements for increased throughput or reduced costs
Annual method review and performance assessment
Industry-Specific Method Development Expertise:
- Pharmaceuticals: API assays, impurity profiling, dissolution testing, cleaning validation
- Environmental: PFAS analysis, pesticide residues, heavy metals, VOC testing
- Food & Beverage: Mycotoxins, food additives, contaminants, nutritional labeling
- Clinical: Biomarker quantification, therapeutic drug monitoring, clinical toxicology
- Cannabis: Potency testing, terpene profiling, pesticide screening, residual solvents
- Industrial: Raw material testing, in-process controls, finished product release
Our Method Development Approach:
- Define analytical targets and requirements
- Design experimental plan using DoE
- Develop initial method conditions
- Optimize for robustness and performance
- Validate against regulatory requirements
- Transfer to production environment
Request a Free Consultation
Whether you require equipment, technical support, or strategic scientific consultancy, our team is ready to assist.