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Key Facts
- End-to-End QbD & AQbD Expertise – Nuvalore applies Quality by Design across both product development and analytical methods, ensuring robust processes, regulatory alignment, and adaptability throughout the entire lifecycle.
- Data-Driven Acceleration with DoE – Leveraging advanced Design of Experiments, we uncover critical variable interactions faster and more cost-effectively than traditional methods, enabling smarter decision-making and stronger submissions.
- Trusted by Global Pharma & Biotech Leaders – Our customized frameworks help companies navigate regulatory complexity, reduce development risks, and achieve smoother technology transfer and scale-up—delivering measurable impact across markets.
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Research institutes, laboratories Research, development
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Nuvalore empowers pharmaceutical and biotech companies to embed quality at every stage of development with Quality by Design (QbD). By combining advanced data analytics, risk management, and regulatory expertise, we help clients accelerate timelines, reduce variability, and strengthen compliance. Our QbD framework aligns seamlessly with global ICH guidelines, enabling efficient processes, fewer deviations, and more confident regulatory submissions.
We bring the same philosophy to analytical methods through Analytical Quality by Design (AQbD). By defining clear Analytical Target Profiles (ATPs), establishing Method Operable Design Regions (MODRs), and applying risk-based strategies, AQbD delivers robust, ...Product Expert
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