Custom Analytical Method Design and Regulatory Validation Solutions
At Leeder Analytical, Method Development and Validation are critical capabilities supporting novel compound analysis, trace detection, and regulatory compliance.
We design, optimise, and validate analytical methods across multiple platforms, delivering precision, reproducibility, and submission-ready data.
Our NATA-accredited processes support industries including pharmaceuticals, environmental monitoring, food safety, and industrial quality control.
What Is Method Development and Validation?
Method development is the creation and optimisation of analytical procedures tailored to specific analytes and sample matrices.
Validation ensures these methods are scientifically robust and meet international standards for regulatory use.
Our full service scope includes:
- Method Development: Design from scratch or adapt literature-based methods
- Method Validation: Rigorous testing to demonstrate suitability
- Method Transfer: Cross-lab transfer with full documentation and training
- Performance Verification: Reassurance that methods stay fit-for-purpose
Complete Method Validation Services
We validate methods to FDA, EPA, ISO, and ICH standards, ensuring your workflows are fit for regulatory and operational use.
| Key Validation Parameters | Validation Applications |
|---|---|
| Accuracy: Verified through recovery studies and certified reference materials Precision: Repeatability intermediate precision evaluation Specificity: Interference testing and matrix effect evaluation Sensitivity: LOD and LOQ determination Linearity: Calibration curve evaluation and working range analysis Robustness: Method performance under deliberate variation testing Uncertainty: Full statistical uncertainty budget development |
• Customer-supplied method validation with data generation • Novel method development from literature adaptation • Matrix-specific method modification and validation • Regulatory compliance validation for FDA, EPA, and international submissions • Method transfer and verification between laboratories • Legacy method update and modernisation • Cross-platform method development and comparison |
What We Use Method Development For
Custom Analytical Solutions
- Novel compound analysis requiring new analytical approaches
- Complex matrix analysis where standard methods are inadequate
- Trace-level quantification requiring enhanced sensitivity
- Multi-analyte methods for comprehensive sample screening
- Rapid analysis methods for high-throughput applications
- Specialised sample preparation for challenging matrices
Regulatory Compliance Support
- FDA method validation for pharmaceutical and food applications
- EPA method development for environmental monitoring
- ISO standard compliance for international acceptance
- Industry-specific method requirements across diverse sectors
- Good Laboratory Practice (GLP) compliant development
- Method harmonisation across multiple regulatory frameworks
Industry-Specific Applications
- Pharmaceutical analysis: Drug development, impurity analysis, dissolution testing
- Environmental monitoring: Emerging contaminants, multi-residue analysis
- Food and beverage: Additive analysis, contaminant screening, nutritional analysis
- Industrial applications: Process monitoring, quality control, troubleshooting
- Forensic analysis: Novel evidence types, trace evidence quantification
- Research support: Academic and industrial research method needs
Advanced Method Development Workflow
| Phase 1: Method Design and Feasibility | Phase 2: Method Optimisation | Phase 3: Comprehensive Validation |
|---|---|---|
| Initial Assessment • Analyte physicochemical property evaluation • Matrix complexity assessment • Regulatory requirement analysis • Performance target establishment • Resource and timeline planningLiterature Review and Method Scouting • Existing method evaluation and adaptation • Regulatory method applicability • Novel approach identification • Technology platform selection • Preliminary method design |
Systematic Parameter Optimisation • Sample preparation development • Chromatographic condition optimisation • Detection parameter tuning • Sensitivity enhancement • Interference eliminationRobustness Assessment • Critical parameter identification • Deliberate variation studies • Ruggedness evaluation • Environmental factor assessment • Operator variability testing |
Complete Performance Evaluation • Accuracy via recovery studies • Precision at multiple concentrations • Specificity testing with interferents • Sensitivity (LOD/LOQ) determination • Linearity and range establishment • Uncertainty budget development |
Method Transfer and Training
We provide complete technology transfer packages, enabling reliable method replication in your laboratory.
Technology Transfer Includes:
- SOPs and method documentation
- Validation data and analysis
- Equipment setup and requirements
- Quality control protocols
- Troubleshooting documentation
Training Services:
- Method-specific and hands-on training
- Instrument operation
- Data QC and interpretation
- Regulatory compliance
- Ongoing technical support
Deliverables
For Method Development
- Full development report with method rationale
- SOPs and QC protocols
- Instrument and setup requirements
- Method performance summary
- Technology transfer documentation
For Validation
- Validation protocol and report
- Statistical analysis of parameters
- Measurement uncertainty data
- Method comparison studies (if applicable)
- Submission-ready compliance documentation
Instrumentation Overview
Our laboratory houses a wide array of analytical instruments to support versatile method development needs:
Liquid Chromatography
- Vanquish UHPLC + Orbitrap MS: High-resolution accurate mass detection
- Quantiva LC-MS/MS Systems (x3): Triple quadrupole precision for quantitative workflows
- HPLC with Detectors: UV, DAD, RI, EC for targeted compound detection
- Ion Chromatography: Conductivity and IC-MS coupling
- UHPLC Systems: For ultra-high pressure and enhanced resolution
Gas Chromatography
- Triple Quadrupole GC-MS/MS: For targeted trace-level detection
- Single Quadrupole GC-MS: General screening and identification
- FID, TCD, FPD Detectors: Flexible for various compound classes
- Headspace GC: Volatile compound analysis
- Thermal Desorption: Direct analysis of air and solid matrices
Specialised Instruments
- FTIR: Rapid molecular identification and quantification
- Gallery Analyser: Automated wet chemistry workflows
- Air Sampling Equipment: Passive and active systems for field sampling
Key Advantages
Comprehensive Expertise
- Multi-platform capabilities
- Regulatory experience across sectors
- Experienced chemists and technical staff
- Advanced Instrumentation Access
Time and Resource Efficiency
- Fast turnaround with dedicated resources
- Reduces internal lab load
- More cost-effective than in-house development
- Risk mitigation
Quality Assurance
- NATA-accredited workflows
- Internal Compliance
- Audit-ready reports
- Fully documented, statistically sound validation
When to Use Method Development Services
Leeder Analytical’s method development is ideal when:
- Internal labs lack time or technical resources
- Novel compounds or complex matrices require tailored methods
- Submission-ready validation is required
- Methods need to be cross-platform or cross-lab transfer
- Emergency testing projects require rapid turnaround
Specialised Development Capabilities
| Air and Volatiles | Sample Preparation Innovation | Emerging Contaminants |
|---|---|---|
| • Workplace and environmental air monitoring • Volatile compound analysis using headspace, SPME, and thermal desorption • Personal exposure and stack emission method development |
• Solid-phase and liquid-liquid extraction protocols • Matrix solid phase dispersion (MSPD) • QuEChERS optimisation and automated methods • Custom clean-up and pre-treatment workflows |
• PFAS detection and quantification methods • Microplastics and pharmaceutical residue workflows • Endocrine disruptors and transformation product profiling • Multi-class contaminant screening protocols |
Regulatory Compliance Support
International Standards
We align all method development with globally recognised standards:
- ISO/IEC 17025
- FDA, EPA, ICH, AOAC, ASTM
Documentation Excellence
- Full method development and validation packages
- Regulatory support for submission
- QA procedures and data traceability
- Statistical analysis and method comparison reporting
Contact Our Team
Need help designing, validating, or transferring an analytical method?
Contact us today to discuss your specific analytical challenges, timeline requirements, method development strategies, and validation needs tailored to your industry and regulatory obligations.Phone:+613 9481 4167
Email:enquiries@leeder-analytical.com
Let us take care of the method, so you can focus on the outcome.
