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- Hall 9 / Booth Number 9-111f
Analytical Method Development, Validation & Transfer Services
Key Facts
- Comprehensive Expertise Across Modalities – Nuvalore develops, validates, and transfers methods for small molecules, biologics, peptides, and complex modalities—delivering versatile solutions tailored to each program.
- Platform Methods & Lifecycle Support – We design scalable platform methods and provide continuous lifecycle management, including post-approval changes, revalidation, and integration of new technologies for long-term reliability.
- Global Regulatory Confidence – Our strategies align with FDA, EMA, and ICH guidelines, combining AQbD, DoE, and risk-based approaches to reduce variability, accelerate submissions, and ensure smooth global scale-up and compliance.
Categories
Research institutes, laboratories Research, development
Product information
Nuvalore provides GMP- and ICH-compliant analytical method development, validation, and transfer services that accelerate timelines, reduce risk, and ensure regulatory success. Our science-driven approach delivers robust methods that reliably measure identity, purity, potency, and stability across the drug lifecycle. Using Analytical Target Profiles (ATPs), Design of Experiments (DoE), and Analytical Quality by Design (AQbD), we design scalable, lifecycle-ready methods built to meet global compliance standards and stand up to regulatory scrutiny.
We tailor validation to each phase of development in alignment with ICH Q2(R2), ensuring accuracy, precision, and reliability under defined conditions. Our met ...Product Expert
