IriSys provides contract pharmaceutical product development and manufacturing services specializing in formulation research and development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and consulting related to the drug development process.
IriSys’ strategic consulting services assist our clients through all stages of product development. Our drug development & regulatory services include the design and implementation of science-based strategic plans that have saved our clients time and money. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.
IriSys’ scientific and regulatory experience includes having moved more than 100 drug products from discovery to Phase I, Phase II, Phase III and into commercialization. IriSys is differentiated from other contract organizations by the more than 125 combined years of pharmaceuticals product development experience of our senior scientists and leadership team.
IriSys aids international companies bringing drugs through the U.S. FDA approval process. We support the special needs of international clients by meeting at your location or hosting your representatives at our facility, providing translations, bringing your products to the U.S., and educating your personnel about FDA regulatory requirements.
IriSys manufactures clinical supplies for all dosage forms and classes of drugs. We also have the capability to manufacture highly potent compounds. Our expertise is reflected by the renewal in 2015 of a five year contract with the National Cancer Institute (NCI)’s Developmental Therapeutic Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI.
Under this agreement, IriSys will be supplying NCI with oral, topical and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys will be responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance.
IriSys performs dosage form development for all phases of human clinical trials [I, II, III] in order to provide a wide variety of world-class pharmaceuticals, as well as commercial pharmaceutical products. Some of the medicinal products we manufacture include tablets and capsules, injectables, and gel, cream, and liquid dosage forms.
IriSys develops formulations for small molecules, proteins and peptides, as well as generics and 505b2 projects.
The Company develops the following dosage forms:
IriSys conducts preformulation development studies to determine the physical and chemical characteristics of the compound of interest, be it a small organic molecule, peptide, or protein. These studies generate the data that are a prerequisite to dosage form development and the data required for the Chemistry, Manufacturing and Controls (CMC) section of an Investigational New Drug application (IND). IriSys provides the following preformulation development studies:
IriSys’ team of analytical chemists is experienced in the development and validation of stability-indicating methods used to quantify drug substance purity and percentage of drug content in a dosage form, including impurities and degradation products. As each analytical method evolves, it is further used to measure conformity to dosage form specifications including dissolution, presence of related substances and product stability.
IriSys provides the following analytical chemistry services:
Regulatory strategic planning
IriSys will create a regulatory plan that…
Product development, processes or procedures evaluation with regard to regulatory compliance
Pre-IND (Investigational New Drug application) meeting package preparation
FDA pre-IND meeting participation
CMC (Chemistry, Manufacturing and Controls) section of IND preparation
IriSys will be responsible for…
IND application preparation & submission
IriSys will be responsible for…
IriSys has been manufacturing commercial supplies of oral tablets and liquids since 2009. We currently have the capacity to produce up to one million tablet batches and 2000 liter liquids.
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