Services/Analytical Development & Validation 08 / Methods that hold up under review
Analytical Development & Validation
Every claim in a dossier rests on an analytical method. We develop, validate and transfer those methods to ICH and compendial expectations, and build the stability and specification packages that reviewers actually interrogate.
Method development and validation
Phase-appropriate method development for assay, impurities and dissolution
ICH Q2 method validation and revalidation
Analytical method transfer between sites and laboratories
Compendial method verification (USP, Ph. Eur., BP)
Stability and specifications
ICH Q1 stability program design and oversight
Specification setting and justification per ICH Q6A
Impurity, degradation and extractables assessment
Out-of-specification and out-of-trend investigations
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