Developing GMP Methods for Solid Analysis

Developing GMP Methods for Solid Analysis

We offer comprehensive cGMP analytical method development, validation, and lot release testing services, specializing in solid-state chemistry and complex solid mixtures. Our expertise includes highly sensitive qualitative and quantitative testing, such as detecting low-dosage APIs (less than 1%) in intricate formulations, all while adhering to FDA, MHRA, and ICH guidelines. We utilize advanced analytical techniques—including X-ray powder diffraction, spectroscopic assays (Raman, NMR, FTIR), dissolution methods, and particle size analysis—to ensure accuracy, precision, and robustness in all stages of pharmaceutical development, from lead optimization to manufacturing. Our team’s deep understanding of the unique challenges associated with solid-state matrix effects enables us to develop and validate tailored methods that surpass the limitations of traditional liquid-based assay guidelines, ensuring reliable performance and regulatory compliance. As a trusted release lab with extensive experience and agency registrations (FDA, DEA, Health Canada), we are committed to providing innovative, science-driven solutions to meet your specific testing and development needs.