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  • An integrated drug development solutions provider
  • Full-service Dosage Form Research & Development services company
  • Product development in the area of Oral Solid Dosage Forms & Liquid Dosage Forms
  • Product development includes formulation development, process development, analytical method development / validation, stability studies & regulatory services
  • Project Management services, which involves coordination with drug substance vendors and drug product manufacturing sites.

    • Formulation Development


  • Preformulation studies
  • Reference product characterization
  • Prototype formulation development
  • Full formulation development
  • Scale up at the manufacturing site
  • Technology transfer documentation
  • Expertise in the field of modified release dosage forms based on multi particulate systems as well as matrix based systems
  • Lab capable of handling products which requires low humidity (Lab can attain % RH of around 30% maintaining the temperature below 25°C)

    • Packaging Development


  • Reference product characterization
  • Packaging development: Product specific requirements, cost considerations
  • Documentation support: Specifications, Tech transfer documents

    • Analytical Development


  • Analytical method development
  • Routine analysis of products under development
  • Analytical method validation
  • Analytical method verification
  • Stability studies
  • Development / preparation of complete specifications
  • Multimedia dissolution on exhibit batches or batches executed at the manufacturing site
  • Analytical method transfers between the reference analytical laboratories (Xylopia) to recipient analytical Laboratory i.e. client’s analytical Laboratory
  • Services like in-vitro testing, method equivalency
  • Drug substance evaluation and verification
  • Centralized server based network with audit trail
  • Drug substance evaluation and vendor qualification process

    • Regulatory Affairs


  • Coordinate and provides regulatory inputs to various departments for document generation
  • Evaluate DMF
  • Coordinate with API suppliers for regulatory requirements
  • Coordinate with the client’s manufacturing site for executed batch documents and other required documentation for regulatory submission
  • Review documents (both development and manufacturing documents) as per the Regulatory agency’s requirements
  • Compilation of relevant dossiers
  • Trained staff on Educe, a software for eCTD compilation
  • Support clients during submissions and responding to queries


    • Project Management & Technology Transfer


  • Create and execute project work plans and revise as appropriate to meet changing needs and requirements.
  • Seamless co-ordination with all the stake holders for technology transfer activities.

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