We know that bringing a product to market—from routine analysis to regulatory submissions—can be a complex and intensive process. That’s why our team works closely with yours by supporting early drug development through a sound and meaningful R&D approach. Whether it’s formulation optimization or product development, we help our clients navigate the complexities of regulatory approval and NDA and ANDA submissions.
With extensive expertise in analytical method development, method transfer and validation, our analytical services support both small and large molecule drug substance and product analysis in liquid, solid and semisolid dosage forms.
- Analytical method development, verification and validation for small molecules and large molecules including oligonucleotides, peptides, proteins, lipids and polysaccharides
- Stability programs supporting drug development through all preclinical and clinical phases including post market study. The programs include stability-indicating method development, forced degradation studies and method validation
- In vitro release test (IVRT) and in vitro permeation (IVPT) studies in compliance with FDA regulations
- Wet chemistry testing for routine raw material and finished product testing
- Dissolution tests for solid dosage forms, sustained release and other unique dosage forms such a liposome, film and transdermal patches
- Method transfer
- Residual solvent tests using compendial methods and customized in-house methods