Our Approach: Quality by Design, Applied End-to-End

At nuvalore, Quality by Design is not a checkbox — it is the framework that guides how we think, plan, and execute.

By integrating analytical and formulation strategy early, we identify critical quality attributes, understand sources of variability, and define design spaces that support consistent performance under real-world conditions. Using DoE-guided development and ICH-aligned method lifecycle strategy, we help teams:

• Reduce development risk and avoid late-stage surprises
• Minimize rework through structured, data-driven optimization
• Build methods and formulations that are scalable, transferable, and inspection-ready

This approach creates clarity early, supports regulatory confidence, and allows programs to progress efficiently toward clinical and commercial milestones.

Why Leading Pharma Choose nuvalore

At nuvalore, we support the development of safe, effective medicines through rigorous science, disciplined execution, and accountable partnership. Our clients rely on us not only for analytical expertise, but for clear thinking and dependable outcomes when development decisions matter most.

Scientific judgment you can trust
Deep analytical and regulatory expertise applied with precision and clarity, supporting development decisions that stand up to scale, transfer, and regulatory scrutiny.

Quality without compromise
GMP-compliant workflows, ALCOA+ data integrity principles, and validated processes embedded throughout the method and product lifecycle, ensuring data remains defensible, consistent, and inspection-ready.

Structured innovation, applied purposefully
Modern technologies and DoE-driven methodologies applied with intent, generating meaningful data, not unnecessary complexity.

True partnership, not transactional execution
Aligned planning, transparent communication, and accountable execution, working as an extension of your team to anticipate challenges early and prevent downstream surprises.

Built for long-term development, not short-term fixes
Methods, formulations, and strategies designed to remain robust beyond a single phase, supporting tech transfer, lifecycle management, and evolving regulatory expectations.

Leadership

nuvalore GmbH was founded in 2024 in Leimen, Germany by Dr. Anamarija Ćurić, an analytical scientist with deep expertise across analytical method development, method lifecycle strategy, and drug product development under GMP conditions.

Dr. Ćurić brings a disciplined, systems-level approach to development challenges, combining scientific rigor with practical execution and a clear understanding of regulatory expectations. She is known for helping teams navigate ambiguity early, identify critical sources of variability, and design analytical and development strategies that remain robust through scale-up, tech transfer, and regulatory review.

Her work emphasizes accountability — developing methods that are scientifically sound, operationally transferable, inspection-ready, and fit for long-term lifecycle management. nuvalore reflects these standards, serving as a trusted partner to development teams who value clarity, reliability, and confidence at every stage of the product lifecycle.

Dr. Anamarija Ćurić
Founder & Managing Director
anamarija.curic@nuvalore.com

Our Facility & Quality System

Our laboratory and quality systems are designed to support development programs as they evolve, from early-stage formulation through GMP manufacturing and post-approval lifecycle management.

• GMP-compliant laboratory supporting analytical and drug product development projects
• ICH-aligned workflows for method development, validation, transfer, and lifecycle management
• Controlled stability storage and forced-degradation capabilities for stress testing and long-term studies
• ALCOA+ data integrity practices applied consistently throughout the data lifecycle.
• Structured documentation and reporting aligned to regulatory expectations
• Design Verification Testing (DVT) support for combination products and delivery systems, ensuring performance, reliability, and user-appropriate function under real-world conditions

Our Services

nuvalore operates as an integrated analytical, formulation, and quality team, supporting development programs with clarity and confidence.

Analytical services
Method development, validation, transfer, characterization, stability studies, and release testing designed to perform reliably under GMP conditions.

Drug product development
Biopharmaceutical formulation development guided by QbD and DoE principles, supporting stability, scalability, and clinical readiness.

Consulting services
Strategic support for GMP implementation, Quality Management Systems, method lifecycle strategy, and laboratory qualification.

Let’s Advance Your Development Together

nuvalore combines scientific rigor, regulatory alignment, and true partnership to help teams navigate complexity and move life-changing therapies forward with confidence.