• Imagen
  • Imagen
  • Imagen
  • What We Do

    API Development :
    Services consists of selection of route of synthesis with reaction scheme, raw material sourcing, isolation of API including stable intermediates, development of cost effective & safe process for API’s meeting pharmacopeia limits & ICH limits. Associated analytical method development & validation, stability assessment, regulatory support for DMF preparation.

    Formulation Development :
    Expertise in developing drug formulations for conventional and specialized dosage forms, including OSD’s, liquids, creams & ointments and injectables. We understand the importance of delivering a quality, stable formulation. Services consists of drug delivery design, analytical method development/ validation, drug stability assessment, regulatory support for submissions of dossiers for all major markets.

    Profiling of API for development :
    Comprehensive testing consisting of chromatographic, spectral, differential scanning calorimetric techniques and particle size distribution.

    Pre-Formulation Studies :
    • Development of suitable dosage forms to achieve enhanced solubility
    • Sustained delivery
    • Enhanced stability
    • Targeted delivery
    • Improved bioavailability
    • Acceptability for specialized use.

    Some of the key attributes tested out during preformulation studies are: Solubility profile, Partition coefficient, pH rate profile, Bulk density, Polymorphism, Particle size distribution, Flow properties, Stability, Dissolution, Drug-excipient interference.


    Formulation development (clinical to commercial)
    • Drug prototype development
    • Process optimization and scale-up
    • Comparative product modification for blinding studies
    • Lab & pilot scale manufacture
    • Packaging & labelling
    • Technology transfer

    Quality by Design (QbD) Program :
    • Define Target Product Profile (TPP)
    • Critical Quality Attributes (CQAs) determined
    • Risk assessment: Link material attributes and process parameters to CQAs
    • Identify Design space using DoE
    • Control strategy for sensitive products (moisture / oxidation)
    • Product life cycle management & continual improvement

    Product Development Plan :
    The product development plan is prepared to assist  development of dosage forms and generally includes following information like patent information, regulatory information, sourcing of API, excipients & packing material, analytical details, innovator / reference(target) product evaluation, design input specification for API, excipients and for product & timelines for the development activities.

    The development  of drug products follows the stages of lab scale, scale up and pilot batches of product with the detailed development report combined into a technical package available to clients.