• 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.
  
  Services
  
  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.