Analytical Method Development for Robust, Regulatory-Ready Results

Analytical method development is the process of designing and optimizing laboratory procedures to measure the critical quality attributes of drug substances and products, such as identity, potency, purity, and stability. These methods provide the foundation for product release and lifecycle quality assurance, enabling consistent, reliable data from early development through commercial manufacturing. For pharmaceutical companies, robust method development is essential to reduce risk, support regulatory submissions, and meet global compliance standards, including FDA, EMA, and ICH guidelines. Key benefits include:

• Support IND/NDA submissions with confidence
• Ensure accurate and reproducible results
• Align with ICH Q2(R2), Q14, and GMP requirements

At nuvalore, our analytical method development process is built on scientific rigor, regulatory foresight, and a deep understanding of your molecule, therapeutic goals, and drug product development strategy. We start by establishing a clear Analytical Target Profile (ATP), defining what the method must measure, the level of accuracy required, and the conditions it must perform under. This forms the strategic foundation for building robust, phase-appropriate methods aligned with ICH Q14 and regulatory expectations.

To ensure method robustness and control, we apply Design of Experiments (DoE) and Analytical Quality by Design (AQbD) principles. These tools allow us to systematically explore variable main effects and their interactions, optimize method parameters, and design for long-term performance. Our development process is anchored in proactive risk assessments, leveraging tools like Ishikawa diagrams to identify and control potential sources of variability and guide development. Our method development process includes:

• Defining the ATP based on product and regulatory requirements
• Selecting stability indicating analytical methods appropriate for the molecule and application, such as HPLC, cIEF, CEX-UV, or CE.
• Optimizing methods using DoE and predictive modeling tools
• Identifying critical method parameters and establishing a data-driven control strategy

Our approach is adaptable. For less complex needs, we design streamlined methods focused on essential performance metrics. For more advanced programs, we implement full AQbD-based strategies, leveraging prior knowledge, multivariate DoE, and defining Proven Acceptable Ranges (PAR) or Method Operable Design Regions (MODR) to enable flexibility and lifecycle control.

Our approach is adaptable. For less complex needs, we design streamlined methods focused on essential performance metrics. For more advanced programs, we implement full AQbD-based strategies, leveraging prior knowledge, multivariate DoE, and defining Proven Acceptable Ranges (PAR) or Method Operable Design Regions (MODR) to enable flexibility and lifecycle control.

Every method we deliver is scientifically sound, regulatory-aligned, and built to perform, from early development through global commercialization. By partnering with nuvalore, companies gain access to deep analytical expertise, frameworks aligned with GMP- and IHC- guidelines, and a proactive, risk-based approach that reduces variability and accelerates timelines. We don’t just deliver test methods, we build scalable, lifecycle-ready analytical solutions that stand up to regulatory scrutiny.

Method Validation Aligned with ICH Guidelines and Project-Specific Needs

Method validation ensures the analytical method consistently produces reliable results under defined conditions. At nuvalore, we design validation protocols aligned with ICH Q2(R2) guidelines and tailored to the phase of drug product development. Our validation approach includes assessment of preapproved key performance characteristics, such as:

• Accuracy and Precision: Ensures results are both correct and consistent across repeated measurements.
• Specificity and Selectivity: Ensuring the method can distinguish the target analyte from impurities and matrix components.
• Linearity and Range: Demonstrating the method provides reliable results across relevant concentration ranges.
• Detection and Quantitation Limits (LOD/LOQ): Defining the method’s sensitivity and minimum detectable limits.
• Robustness and System Suitability: Assessing performance under variable conditions and establishing suitability criteria.

For pharmaceutical and biotech companies, robust method validation is essential for supporting regulatory submissions, demonstrating process control, and ensuring patient safety. Nuvalore provides tailored validation strategies that reduce rework, accelerate timelines, and ensure your methods meet global regulatory expectations with confidence.

Method Transfer for Seamless Scale-Up and Global Alignment

Nuvalore supports method transfer as a critical step in scaling analytical methods from development through global implementation – within the same organization or to external partners. We apply a structured, risk-based approach to ensure reliable and reproducible results. Our transfer support includes:

• Alignment of method requirements and expectations between sending and receiving sites
• Assessment of method readiness based on development and validation data
• Support for documentation and procedural standardization
• Technical guidance to ensure smooth handover and consistent execution

We work closely with your internal teams or external partners to enable efficient knowledge transfer and reproducibility across labs. By integrating lifecycle principles and scientific rigor, we help reduce variability, support global operations, and accelerate time to routine use.

Lifecycle Management and Continuous Improvement

At nuvalore, we embed lifecycle thinking into every method we develop, ensuring long-term capability, compliance, and adaptability. Our lifecycle support includes:

• Laufende Überwachung der Methodenleistung
• Post-approval changes and revalidation
• Continuous improvement and integration of new technologiesKontinuierliche Verbesserung und Integration neuer Technologien

Each method is developed in accordance with ICH Q14 and validated in alignment with ICH Q2(R2), with results documented in test method instructions. Any post-development modifications are carefully coordinated with clients through established change management procedures and risk assessments.

Let’s Build Your Next Method with Confidence

Outsourcing analytical method development, validation, and transfer offers strategic advantages, from gaining specialized expertise to accelerating timelines and reducing internal burden. At nuvalore, we offer more than technical execution; we provide an end-to-end partnership grounded in scientific rigor, regulatory alignment, and operational flexibility. Leading pharmaceutical and biotech companies choose nuvalore for our:

• Decades of experience in method development and regulatory strategy
• End-to-end support from feasibility to global implementation
• Deep scientific expertise across small molecules, biologics, peptides, and complex modalities
• Proven frameworks aligned with ICH Q2(R2), Q14, and GMP standards
• Tailored project design based on molecule, platform, and business goals

Whether you are preparing for IND/CTA filing or scaling for commercial production, we help you reduce risk, improve method reliability, and accelerate regulatory success.

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