Method Development & Validation
Method Development & Validation ensures that analytical, mechanical, thermal, and biological testing methodologies are accurate, precise, sensitive, specific, and reproducible for their intended purpose. This is critical when no suitable standard method exists, when materials require specialized workflows, or when regulatory submissions demand validated and defensible analytical procedures.
As products evolve, whether new polymers, coatings, medical devices, biomaterials, diagnostics, nanomaterials, or pharmaceuticals, existing methods often fall short. Materials Metric develops fit-for-purpose analytical methods that align with your material’s chemistry, structure, performance attributes, and regulatory pathway. Our validations follow rigorous criteria aligned with ICH, ISO, USP, ASTM, FDA, and CLSI guidelines, ensuring data quality, reliability, and regulatory acceptance.
Materials Metric develops and validates methods for:
Chemical analysis (purity, identity, degradation, impurities)
Mechanical testing (strength, fatigue, modulus, adhesion, nanoindentation)
Thermal analysis (DSC, TGA, DMA, TMA)
Biological assays (cytotoxicity, bioactivity, immunological endpoints)
Spectroscopic techniques (FTIR, Raman, UV-Vis, NMR)
Contaminant screening (residuals, extractables, leachables, trace metals)
Our custom methods are designed to deliver high-confidence, reproducible data across R&D, QC, manufacturing, and regulatory programs.
Our Method Development Capabilities
1. Analytical & Chemical Methods
HPLC, GC-MS, LC-MS workflows
FTIR, Raman, UV-Vis, Fluorescence, NMR
ICP–MS/OES, AAS, XRF elemental profiling
Residual solvents, monomers, stabilizers, degradation products
2. Material & Structural Characterization
SEM/TEM/AFM imaging and quantification
Surface chemistry (XPS, EDS, EPMA)
XRD for phase and crystallinity evaluation
3. Mechanical & Thermal Test Methods
Tensile, compression, shear, peel, adhesion
Fatigue, wear, friction
DSC, TGA, DMA, TMA
4. Biological & Functional Assay Methods
Cell viability, cytotoxicity, activation markers
Antimicrobial and biofilm efficacy
Drug release, functional coating performance
Method Development & Validation Workflow
1. Analytical Strategy & Requirement Definition
We define analytical goals, sample characteristics, regulatory needs, and performance expectations.
2. Method Design & Prototype Development
Selection of instrumentation, sample preparation, detection approaches, and operating parameters.
3. Optimization & Refinement
Improving sensitivity, resolving power, reproducibility, and robustness.
4. Validation
Execution of full validation per applicable guidelines, generating a defensible method ready for QC, R&D, or regulatory submission.
5. Method Transfer & Implementation Support
Providing SOPs, training, documentation, and support for scaling into GLP/GMP or manufacturing environments.
Why Choose Materials Metric
Materials Metric delivers scientifically rigorous, regulatory-aligned, ISO 9001:2015–supported method development and validation across chemical, mechanical, thermal, and biological domains.
We provide:
Methods engineered specifically for challenging or novel materials, coatings, biomaterials, diagnostics, and devices
Precise analytical design supported by advanced instrumentation and expert interpretation
Rapid, transparent communication and collaborative planning
Validation packages aligned with ICH, USP, ISO, ASTM, and FDA expectations
End-to-end support from early feasibility to regulatory submission
Your method will not only work, it will stand up to scientific scrutiny, regulatory review, and long-term operational use.