Iris Pharma is a service provider of analytical testing and validation to the pharmaceutical industry, and smaller biotech or start-up. In a GLP environment we develop, customize and validate assays of drug candidates and metabolites in biological matrices such as tears, conjunctiva, bulbar conjunctiva, aqueous humor, cornea, vitreous, retina, choroid, sclera, plasma and blood in order to support preclinical and/or biopharmaceutics and clinical pharmacology programs.
BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION
In addition to a long list of available bioanalytical methods, Iris Pharma develops custom methods and can also improve and validate clients' existing methods. We offer bioanalytical method validation to support international submissions of investigative and new drug substances and products:
Iris Pharma can process samples using mass spectrometry, chromatography and other analytical techniques:
- Mass spectrometry: a triple quadrupole mass spectrometer system (RRLC-MS/MS) to dramatically increase the speed of analysis and the detection level.
- Classical chromatography: expertise in chromatography using routinely HPLC coupled with different detectors (MS, RID, FLUO, UV).
- Immunoanalysis : EIA-RIA-ELISA measurement.
- Radioactivity counter (beta, gamma).
Iris Pharma conducts method validations before and during the bioanalysis of test samples in accordance with recognized international recommendations and guidelines, including those issued by the :
- The United Stats Food and Drug Administration (FDA).
- The International Conference on Harmonisation (ICH).
- Organization for Economic Cooperation and Development (OECD).