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About site: http://www.irisys.com/

Title: Biotechnology and Pharmaceuticals/Pharmaceuticals/Outsourcing - IriSys Research & Development, LLC Pharmaceutical contract research and development specializing in improving bioavailability of insoluble compounds, generating data for the CMC section of the IND, and formulation development.

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San Diego's Pharmaceutical Dosage Form and Drug Development Company - Irisys

Pharmaceutical Dosage Form Development Company

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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 facility. IriSys has provided product development contract services to Fortune 100 companies as well as virtual companies worldwide.

Specialized Formulations Case Studies Why Irisys? Contact Irisys

8810 Rehco Road, Suite F, San Diego, CA 92121Tel (858) 623-1520 Fax (858) 623-1525

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Pharmaceutical	contract	research	and
development	specializing	in	improving	bioavailability
of	insoluble	compounds,	generating	data
for	the	CMC	section	of
the	IND,	and	formulation	development.

http://www.irisys.com/

IriSys Research & Development, LLC 2008 September

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Pharmaceutical contract research and development specializing in improving bioavailability of insoluble compounds, generating data for the CMC section of the IND, and formulation development.

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