Strategic Consulting

IriSys provides its clients drug development guidance and regulatory strategies at all stages of the U.S. Food and Drug Administration (FDA) drug approval process, including special assistance for international clients. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.

Drug Development & Regulatory Services

IRISYS WILL BE YOUR PARTNER AND GUIDE YOUR COMPANY THROUGH THE U.S. FDA DRUG APPROVAL PROCESS.

IRISYS EXPERIENCE & EXPERTISE

IriSys’ management has a deep understanding of current regulatory philosophy and standards. We have direct experience in working with the Food and Drug Administration (FDA) at all levels. Our history of successful drug development spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.

THE IRISYS ADVANTAGE

IriSys creates tailored plans for achieving product approvals as quickly and cost-effectively as possible. Decades of experience working with regulators gives us the insight to pursue non-traditional approaches. We design and implement science-based strategic plans that have saved our clients time and money.

WHAT IRISYS CAN DO FOR YOU

IriSys specializes in helping U.S. and foreign companies through the entire FDA regulatory process. We personalize our services to the needs of each client as new products are moved from the lab to commercialization. IriSys will work with or function as your Head of Regulatory. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.

For foreign companies, IriSys will support your special needs by meeting at your location, providing translations, bringing your products to the U.S., and educating your personnel about FDA regulatory requirements.

Pre-IND Meetings with FDA

Gerald Yakatan, Ph.D., Founder, Chairman & CEO of IriSys, has decades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience. He interacts with high-level FDA personnel and has planned and engaged in numerous FDA meetings with U.S. and foreign clients. Dr. Yakatan leads a management team that has a deep understanding of current regulatory philosophy and standards. We have experience working directly with the FDA at all levels. IriSys’ history of successful drug development spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.

Pre-IND (Investigational New Drug application) meeting package & presentation 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 & follow-up

IriSys will:

  • Accompany you to the Pre-IND Meeting
  • Give your company presentation at the meeting
  • Review the FDA feedback and provide strategic advice for advancing your product

IND & ANDA Filings

IriSys will work with, or function as, your Head of Regulatory to prepare and submit regulatory filings to the FDA. We personalize our services for each client based upon your products and internal capabilities.

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

IriSys will be responsible for:

  • Data generation and reports
  • Preparation of the CMC section for submission

IND & ANDA (Abbreviated New Drug Applications) preparation &a submission

IriSys will be responsible for:

  • Preparation of your IND and ANDA application in eCTD format
  • Submission of the IND and ANDA to the FDA

FDA Regulatory Strategies

IriSys creates tailored plans for achieving product approvals as quickly and cost-effectively as possible. Decades of experience working with regulators gives us the insight to pursue non-traditional approaches. We design and implement science-based strategic plans that have saved our clients time and money.

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
  • Includes a risk assessment
  • Considers your timeline and financial resources

Evaluation of product development, processes and procedures for regulatory compliance

IriSys will…

  • Analyze the scientific basis and history of your product
  • Determine what further testing is needed 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

Phase 1 & 2 Protocol Design and CRO Management

The IriSys team has expertise that covers the entire development path, including the organization and supervision of Phase 1 and Phase 2 clinical trials.

Clinical Trial Design

IriSys is well-versed in the design, methodology and reporting requirements for Phase 1 and Phase 2 clinical trials. We will work with your clinical staff to create a clinical study plan specific for your needs.

CRO Management

IriSys will identify a Contract Research Organization (CRO) that provides clinical trial services appropriate for your product and we will manage interactions on your behalf.

International Company Assistance

IriSys has helped numerous foreign companies take their new drug products through the entire FDA regulatory process. We offer customized services that support the special needs of our international clients. IriSys is privileged to have worked with companies in Australia, China, Japan, Korea and Russia.

Bringing a client’s products into the U.S.

IriSys helps international companies by…

  • Providing strategy and guidance throughout the U.S. FDA approval process
  • Meeting at the client’s location or hosting representatives at IriSys
  • Providing translations
  • Educating the client’s personnel about FDA regulatory requirements