OUR SERVICES

At nuvalore, we provide end-to-end GMP analytical method development, validation, and transfer services aligned with ICH Q14/Q2(R2) requirements

— supporting drug product development from early feasibility through full validation. Our scientists apply Quality by Design (QbD) and Design of Experiments (DoE) principles to create phase-appropriate, robust methods that deliver consistent and reliable results.

From feasibility through inter-laboratory transfer, every step is scientifically justified, fully documented, and ready for regulatory submission.

This integrated lifecycle approach minimizes variability, reduces rework, and ensures smooth method implementation — accelerating your path to regulatory approval.

Nuvalore offers drug product characterization and routine analytical services to ensure product quality, stability, and regulatory readiness.

Our portfolio combines compendial testing with advanced analytical techniques to support every stage of drug product and pharmaceutical development.

Our expertise includes:

• Routine compendial testing — pH, osmolarity, clarity, subvisible particles, and extractable volume
• Chromatographic methods — Advanced HPLC-based methods are applied for structural and purity assessments:
  • • RP-HPLC and peptide mapping for identity and purity
    • IEX-UV for charge variant profiling
    • SEC SEC for aggregate detection
    • HIC-HPLC for hydrophobic interaction analysis

• Capillary electrophoresis (CE) — Used for high-resolution separation and characterization of proteins and charge variants
• Imaged Capillary Isoelectric Focusing (icIEF) — For separating proteins based on their isoelectric points (pI)
• Surfactant analysis — Polysorbate 20/80 and poloxamers are quantified using HPLC-CAD, supporting formulation stability studies
• ELISA-based assays — for binding activity testing, particularly for biologics and antibody-based products
• Dissolution and release testing — Performed on bulk materials and finished dosage forms to evaluate drug release profiles
• Force measurement — To assess mechanical strength, activation force, and device–drug performance

These studies help define Critical Quality Attributes (CQAs), confirm molecular integrity, and ensure consistent performance from development through commercial release.

Nuvalore delivers ICH-compliant stability studies to ensure your drug product maintains its quality, safety, and efficacy throughout its shelf life. Our tailored programs include long-term, accelerated, stress, and in-use stability testing in full alignment with ICH guidelines. From protocol design to data evaluation, we manage every step with complete traceability and regulatory confidence — providing the data you need to define shelf life, confirm storage conditions, and support GMP analytical documentation global regulatory submissions.

Nuvalore offers GMP-compliant release testing services to verify that each batch meets predefined quality specifications before market release. We perform release testing of drug substances, intermediates, and finished products using validated analytical methods and compendial procedures in accordance regulatory requirements. Our team ensures timely execution, accurate documentation, and clear data reporting to support batch certification and product approval. With precise, reliable analytics, we help our partners maintain quality consistency and ensure that every product delivered is safe and compliant.

Nuvalore provides expert consulting services that integrates deep scientific understanding and regulatory expertise to strengthen analytical and quality programs. We partner with clients to design, implement, and refine systems that ensure GMP compliance and operational excellence — building efficient, sustainable laboratory operations aligned with global quality standards.

Our consulting expertise includes:

• GMP implementation and laboratory qualification
• Establishment of Quality Management Systems (QMS)
• Analytical method lifecycle management and regulatory readiness
• Qualification and validation of laboratory equipment

We also provide statistical experimental design (Design of Experiments, DoE) consulting in both GMP-regulated and non-GMP settings. These services enhance efficiency, reproducibility, and scientific insight in early-stage research, assay development, and exploratory studies.

Our DoE consulting supports:

• PhD candidates and academic researchers conducting complex cell-culture or assay-optimization studies
• Biotech innovators refining ligand-binding assays or formulation development
• Laboratories seeking reproducible, data-driven experimental strategies

At nuvalore, we approach every project as a collaborative partnership — helping clients implement sustainable improvements that enhance decision-making, accelerate development, and maintain compliance from early research through commercialization.