Drug Development & Regulatory Services

IriSys provides the following full complement of services:

• Regulatory strategic planning
     o IriSys will create a regulatory plan that…
          o Is based on your specific product and proposed application
          o Includes 505(b)(2) strategy assessment
               o For sponsors relying upon clinical data or literature produced by other companies or entities
          o Includes a risk assessment
          o Considers your timeline and financial resources
• Product development, processes or procedures evaluation with regard to regulatory compliance
     o IriSys will…
          o Analyze the scientific basis and history of your product
          o Determine further testing to fulfill regulatory requirements
          o Conduct Preformulation Development Studies
          o Conduct Dosage Form Development Activities
          o Prepare Specialized Formulations as needed
          o Provide world-class Analytical Chemistry and Preclinical Development Services
• Pre-IND (Investigational New Drug application) meeting package preparation
     o IriSys will…
          o Meet with you to prepare for a pre-IND Meeting with the FDA
          o Prepare a Briefing Book that includes a rationale for recommended clinical studies
          o Prepare your FDA Pre-IND Meeting Presentation
• FDA pre-IND meeting participation
     o IriSys will…
          o Accompany you to the Pre-IND Meeting
          o Give your company presentation at the meeting
          o Review the FDA feedback with you
          o Provide advice for moving forward
• CMC (Chemistry, Manufacturing and Controls) section of IND preparation
     o IriSys will be responsible for…
          o Data generation
          o CMC reports
• IND application preparation & submission
     o IriSys will be responsible for…
          o Preparation of your IND application
          o Submission of the IND to the FDA
• Drug product guidance at all stages of development
     o IriSys provides…
          o cGMP Manufacturing & Formulation Services
          o Phase I and Phase II Clinical Plans
          o Commercial product manufacturing
          o Organization & supervision of Phase I and Phase II clinical trials