IriSys provides pharmaceutical product development
contract services specializing in formulation development, tablet formulation, cGMP manufacturing of clinical trial materials, and consulting
related to the drug development process.
IriSys’ custom approach to drug development is supported
by the Company’s scientific and regulatory experience
in moving over 100 drug products from discovery to Phase
I, Phase II, Phase III and, to commercialization. IriSys
provides contract services related to the development of
small and large molecules with a focus on formulation and
cGMP manufacturing of clinical trial materials for Phase
I and Phase II studies. The Company is differentiated from
other contract organizations by the more than 125 years of
pharmaceutical product development experience of its senior
scientists in moving products from discovery to commercialization.
IriSys’ scientists have contributed to the academic
environments of the University of Michigan, University of
Texas at Austin, State University of New York at Buffalo
and University of California, San Diego and, to the growth
of companies like Warner Lambert/ Parke Davis, Tanabe Seiyaku,
Avanir Pharmaceuticals, Schering Plough, Key Pharmaceuticals,
and the Dow Chemical Company.
IriSys initiates each drug development process with major
consideration for implementing the most effective regulatory
strategy to achieve near and long term goals. The Company
believes potential issues addressed early will accelerate
overall development time.
IriSys concentrates on generating data to support the rational
development of a dosage form that will most accurately demonstrate
a compound’s therapeutic capabilities. A dosage form
development program generally includes preclinical preformulation
studies, excipient compatibility studies, analytical methods
development and validation, pharmaceutical formulation development and optimization,
stability studies, preparation of the Chemistry, Manufacturing
and Controls (CMC) section of the Investigational New Drug
(IND) application, manufacturing process development, cGMP
manufacturing of clinical trial materials, and formal stability
studies according to ICH Guidelines. IriSys maintains a cGMP
IriSys has provided product development contract services
to Fortune 100 companies as well as virtual companies worldwide.