WHAT WE DO……

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• 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……

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• 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……

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• 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……

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• Short development time

• Cost-effective development

• Reduced risk

• Innovative formulations

• Potentially patentable drug products

• Robust and easily scalable processes

• CMC documentation support