R&D & Quality

Innovation and compliance as one system - from formulation to commercial supply.

Quality Built in From Day One: R&D to Commercial Scale

At Finecure, formulation development and regulatory compliance function as a single, unified system. Products engineered at our DSIR-recognised R&D centre scale seamlessly to commercial production using identical equipment trains-minimizing technical risk and accelerating time-to-market. Every batch is released against rigorous standards, aligned with official pharmacopoeial monographs or stringent in-house specifications. By embedding Quality by Design (QbD) principles across the entire product lifecycle, we ensure purity, safety, and consistent drug delivery are engineered into the process from day one.

    Technical & Compliance Pillars

  • DSIR-Approved R&D Centre

    A Formulation and Development team developing complex generics, modified-release systems and fixed-dose combinations, with technology transfer from laboratory to commercial scale.

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  • Quality Assurance & Traceability

    A quality management system built on Quality by Design, with end-to-end batch traceability, 21 CFR Part 11 data integrity and continuous audit-readiness against USFDA and WHO-GMP standards.

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  • Analytical Research

    HPLC, GC and UV-Vis spectroscopy for method development, impurity profiling and release testing, with 24/7-monitored stability chambers running ICH studies across all climatic zones.

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  • Global Regulatory Compliance

    A regulatory affairs division supporting market entry across 20+ countries with CTD, eCTD and ACTD dossiers, DMF support and ready-to-file in-licensing opportunities.

  • Finished Dosage Forms

    254 formulations across seven therapeutic verticals - oral solids, modified release, dispersible, liquids, sterile injectables and topicals.

    Discuss CDMO & Out-Licensing

Scientific and manufacturing support for global partners

Finecure provides formulation development, analytical validation and regulatory documentation as one service, so a partner entering a new market works with a single organisation from molecule to dossier.

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