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IriSys LLC

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About IriSys LLC

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... Show more »

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.

Selected Publications

  • Yakatan, G., Avrin, W. (2011) Establishing a company in China. Pharmaceutical Outsourcing: Discovery and Preclinical Services, Pharmamedia, Inc., 147-166.
  • Marier, J. F., Pope, L. E., Yakatan, G. J., Berg, J. E., Stiles, M., & Vachon, P. (2004). Influence of concomitant quinidine administration on dextromethorphan disposition in rats. Journal of Veterinary Pharmacology and Therapeutics, 27, 111-114.
  • Pope, L.E, Khalil, M.H., Berg, J.E., Stiles, M., Yakatan, G.J., Sellers, E.M. (2004). Pharmacokinetics of dextromethorphan after single or multiple dosing in combination with quinidine in extensive and poor metabolizers. Journal of Clinical Pharmacology, 44(10), 1132-1142.
  • Sacks, S. L., Thisted, R. A., Jones, T. M., Barbarash, R. A., Mikolich, D. J., Ruoff, G.E., Jorizzo, J. L., Gunnill, L. B., Katz, D. H., Khalil, M. H., Morrow, P. R., Yakatan, G. J., Pope, L. E., & Berg, J. E. (2001). Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial. Journal of the American Academy of Dermatology, 45(2), 222-230.
  • Thueson, D.O. & Yakatan, G.J. (1991). Anti-Allergy Drugs: Present and Future. Drug Therapy for the 1990s Clinical Pharmacology-Therapeutics and Toxicity, Forum Medicum, Inc., 1-13.
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Certifications & Qualifications

cGMP FDA Inspected GMP

Diversity Certificates

Small business

Our Services (93)


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Lyophilization

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Solid Dosage Formulation

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Topical Formulation

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Controlled Release Systems

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Parenteral Formulation Development

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Batch Release Testing

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Clinical Trials Supply Manufacturing

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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... Show more »

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.

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Pharmaceutical Formulation

Price on request

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... Show more »

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:

  • Tablets
  • Capsules, powder-filled
  • Capsules, liquid-filled
  • Oral solutions and suspensions
  • Topical products
  • Injectables
  • Controlled release products
  • Sustained release products
  • Pellets
  • Microspheres
  • Lyophilized products
  • Animal study materials
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Drug Preformulation

Price on request

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... Show more »

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:

  • Pka and pI
  • Partition coefficient and distribution coefficient as a function of pH
  • pH-solubility profile
  • Intrinsic solubility
  • pH-stability profile at accelerated temperatures
  • Accelerated stability studies
  • Dissociation constants
  • Hygroscopicity analysis
  • Lipophilicity analysis
  • Moisture analysis
  • Excipient compatibility studies
  • Salt formation characteristics determination
  • Accelerated stability studies
  • Viscosity analysis
  • Disintegration studies
  • Dissolution studies
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Analytical Method Development

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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... Show more »

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:

  • Reference standard characterization
  • Analytical methods development
  • Stability-indicating method development
  • Impurity profile generation
  • Degradation product identification
  • Analytical methods qualification
  • Analytical methods validation
  • Dissolution testing according to USP
  • Dosage unit analysis for potency, purity and content uniformity
  • Excipient testing
  • Physical accelerated stress testing
  • Chemical accelerated stress testing
  • Specification development
  • Chromatographic system development
  • Identification of conditions required for optimal stability
  • Container/closure testing and selection
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Regulatory Affairs Consulting

Price on request

Regulatory strategic planning

IriSys will create a regulatory plan that…

  • Is based on your specific product and proposed application
  • Includes 505(b)(2) strategy assessment
    • For sponsors relying upon clinical data or literature produced by other companies or entities
  • Includes a risk assessment
  • Considers your... Show more »

Regulatory strategic planning

IriSys will create a regulatory plan that…

  • Is based on your specific product and proposed application
  • Includes 505(b)(2) strategy assessment
    • For sponsors relying upon clinical data or literature produced by other companies or entities
  • Includes a risk assessment
  • Considers your timeline and financial resources

Product development, processes or procedures evaluation with regard to regulatory compliance

IriSys will…

  • Analyze the scientific basis and history of your product
  • Determine further testing to fulfill regulatory requirements
  • Conduct Preformulation Development Studies
  • Conduct Dosage Form Development Activities
  • Prepare Specialized Formulations as needed
  • Provide world-class Analytical Chemistry and Preclinical Development Services
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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request

Pre-IND (Investigational New Drug application) meeting package preparation

IriSys will…

  • Meet with you to prepare for a pre-IND Meeting with the FDA
  • Prepare a Briefing Book that includes a rationale for recommended clinical studies
  • Prepare your FDA Pre-IND Meeting Presentation

*FDA pre-IND meeting... Show more »

Pre-IND (Investigational New Drug application) meeting package preparation

IriSys will…

  • Meet with you to prepare for a pre-IND Meeting with the FDA
  • Prepare a Briefing Book that includes a rationale for recommended clinical studies
  • Prepare your FDA Pre-IND Meeting Presentation

FDA pre-IND meeting participation

IriSys will…

  • Accompany you to the Pre-IND Meeting
  • Give your company presentation at the meeting
  • Review the FDA feedback with you
  • Provide advice for moving forward

CMC (Chemistry, Manufacturing and Controls) section of IND preparation

IriSys will be responsible for…

  • Data generation
  • CMC reports

IND application preparation & submission

IriSys will be responsible for…

  • Preparation of your IND application
  • Submission of the IND to the FDA
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Custom Manufacturing

Price on request

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.

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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GMP Auditing

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HPLC

High Performance Liquid Chromatography
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Pharmacology & Toxicology

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In vitro Disease Models

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Cells and Tissues

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Manufacturing Consulting

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Non-Sterile Manufacturing

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Sterile Manufacturing

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Parenteral Manufacturing

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Aerosol Manufacturing

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Pharmaceutical Manufacturing

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Peptide Manufacturing

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Semisolid Manufacturing

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Solution and Suspension Manufacturing

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Tablet Manufacturing

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Topical Manufacturing

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Nonclinical Research

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Blister Packaging

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Clinical Trial Packaging

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Cream and Ointment Packaging

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Label Printing

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Solid Dosage Packaging

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Aseptic Processing

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Liquid Chromatography (LC)

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Photostability Studies

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Engineering and Fabrication

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Preclinical Study Design

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In vivo Drug Efficacy Testing

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Contract Services Directory

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Quality Assurance

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R&D Services

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Cell Culture Scale-Up

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Product Quality Control

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Product Stability Testing

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Chemical Stability Testing

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Technology Transfer and Licensing

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Toxicology

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Transdermal/Transmucosal Drug Delivery Systems

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Wet Chemical Analysis

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Analytical Chemistry Services

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Formulation Services

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Business Development, Marketing & Operations

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Bioanalytical Assays

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Business Development Consulting

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Regulatory Affairs Services

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Strength Analysis

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Chromatography

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Physical Analysis Methods

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Manufacturing Services

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Biology

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Separation/Purification Services

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Mammalian Cell Culture

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Drug Discovery & Development

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Packaging Services

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Clinical Research

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Animal Models and Studies

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Chemistry and Materials

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Clinical Trials, Consulting, and Management

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Product Development, Testing, and Packaging

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Bioanalysis

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Analytical Method Validation

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Assay Development

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Bioanalytical Analysis LC/MS/MS

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Biological Testing

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Phase I Clinical Trials

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Phase II Clinical Trials

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Chemistry, Manufacturing and Controls (CMC)

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Consulting

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Contract Development And Manufacturing Organization (CDMO)

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Contract Packaging

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Project Management

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Contract Research

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Solubility and Dissolution Testing

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Dosage Form Development

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Drug Development

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Ampoule Filling

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Capsule Filling

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Pre-Filled Syringe Manufacturing

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Vial Filling

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Forced Degradation Studies

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Louis Scotti

Vice President Business Development

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