Analytical Method Development and Validation

We support small molecules, biologics, peptides, oligonucleotides, and endogenous compounds across various matrices including drug substance, drug product, plasma, serum, and topical formulations.

Yes, validation follows ICH Q2(R2) and USP<1225>guidelines. For bioanalytical applications we adhere to ICH M10 guidance. All results are documented in audit-ready reports formatted for regulatory submission.

We provide full method transfer support including comparative testing between sites, inter-laboratory verification, and on-site training to ensure your team can execute the method effectively and maintain the validated state.

Yes, stability-indicating assays are a standard part of our development. We perform forced degradation studies under stress conditions to demonstrate specificity for the active ingredient against its degradation products.

You will receive a detailed method development report, a full validation report, a standard operating procedure (SOP), and a transfer protocol if applicable. All documents are designed to support regulatory filings.

Yes, the level of validation is scoped per project. Early-phase methods may focus on key parameters, while late-phase and commercial methods undergo full ICH validation with robustness and transfer elements.