WHAT WE DO……

  • Provide value-added product development services

  • Develop innovative manufacturing processes that are efficient, cost-effective, easily scalable and reproducible

  • Conduct pre-formulation studies

  • Develop and validate robust analytical Methods

  • Manufacture Phase CTM materials (in collaboration with a CMO)

  • Conduct stability studies

  • Employ commercially available excipients that meet IID limits, thereby de-risking long term project goals

PARTNERING WITH YOU……

  • Solve challenging drug delivery problems using innovative technologies

  • Devise a plan that addresses API availability and budget constraints

  • Work closely to ensure timely completion of formulation development, manufacturing of clinical trial materials and regulatory submissions

  • Provide unencumbered access to project activities as needed throughout the development phases

  • Provide opportunity to change scope of work without bureaucratic hurdles

  • Convene biweekly meetings to review project progress

HOW WE DO IT……

  • Utilize QbD-based product design and development

  • Employ phase-appropriate development strategy

  • Leverage ExxPharma’s proprietary technologies

  • Utilize continuous and semi-continuous manufacturing processes

  • Conduct extensive in vitro product performance studies

  • Utilize appropriate physicochemical tools to characterize materials

  • Manufacture CTM in DEA-certified cGMP-compliant facility

  • Conduct stability studies under ICH conditions

BENEFITS FOR YOU……

  • Short development time

  • Cost-effective development

  • Reduced risk

  • Innovative formulations

  • Potentially patentable drug products

  • Robust and easily scalable processes

  • CMC documentation support