Method Development / Material Release
Leverage our expert application of regulatory standards, chemistry expertise and advanced instrumentation to support your drug development. We develop efficient, accurate, reliable analytical methods to accelerate and streamline your project.
Tailored to your specific needs, we develop and improve analytical methods by optimizing our resources. Our consultative approach provides effective and efficient communication through the duration of your project. You’ll receive comprehensive reports including:
- Analytical methods
- All test results
- Graphs and calculations
- Sample raw data (e.g., GC/HPLC chromatograms)
Our flexible laboratory team has extensive experience in designing and executing protocols for method development and validation, verification and transfer.
We cover procedures for:
- Drug formulations
- Personal care products
- Raw materials
Working under strict compliance with cGMP requirements, our skilled scientists base our operations on detailed SOPs and stringent quality assurance practices. Our advanced analytical techniques measure accuracy, precision, specificity, limit of detection/limit of quantitation (LOD/LOQ), linearity, range and robustness:
- HPLC: UV variable wavelength, refractive index (RI), photo diode array detectors
- GC: Flame ionization detector (FID), thermal conductivity detector (TCD), direct injection and headspace analysis
- Atomic absorption spectrophotometry (flame)
- UV/visible spectroscopy
Rely on our capabilities to develop and validate a wide variety of other analytical methods for small molecules and biologics. Identification tests, limit tests, assays and quantitative analyses are four methods required for various stages of drug development. We develop these methods using advanced analytical techniques such as:
- Thermal analysis
- Vapor sorption
- Particle size
All methods are developed and validated according to International Conference on Harmonisation (e.g., ICH Q2(R1), Q2B, and Q6A) and FDA guidelines.
For complex methods, our experienced chemometricians design experimentation requiring principal component analysis or partial least squares regression. We also have significant experience with detecting and quantifying minor amounts of amorphous or crystalline forms in both drug substances and drug products.
Our experts have successfully transferred many types of methods into our leading-edge laboratory, and we can also transfer developed methods to your production site. By partnering with us, you can be sure of regulatory-driven and phase-appropriate methodology.