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