About Us

About Us

IriSys provides contract pharmaceutical product development and manufacturing services, specializing in formulation R&D and cGMP (current Good Manufacturing Practices) manufacturing of clinical trial materials and specialty pharmaceutical products. We also offer strategic consulting related to the drug development process, including customized services for international clients. Our headquarters, laboratories and state-of- the-art manufacturing facility are located in San Diego, California.

Under the direction of founder and CEO Gerald J. Yakatan, Ph.D., the IriSys team has built a reputation for excellence and timeliness in pharmaceutical development services.

IriSys’ scientific management includes prominent pharmaceutical product development leaders from industry and academia. Their years of hands-on experience with every facet of pharmaceutical research and development enables the IriSys team to bring our clients’ new products to the market quickly and efficiently.

EXPERTISE THAT DISTINGUISHES IRISYS

IriSys’ leadership team has the acumen and breadth of understanding to direct our technical, operations and support staff in providing exceptional services for our clients.

Learn More About Our Leaders

Who we are

  • Founded in 1996 to focus on pharmaceutical science and industrial pharmacy
  • Highly qualified staff with technical, regulatory and clinical competencies
  • Successful track record with drugs of various classes and physicochemical properties
  • Demonstrated expertise and compliance with cGMP regulations
  • Experienced in bringing products to the market quickly and efficiently

Whom We Serve

  • A wide range of clients, partners and collaborators
  • Both U.S. and international companies
  • Start-up to mid-tier biotech companies
  • National Institutes of Health (NIH)
    • Therapeutics for Rare and Neglected Diseases (TRND)
    • National Center for Advancing Translational Sciences (NCATS)
    • Bridging Interventional Development Gaps (BrIDGs) Program
  • National Cancer Institute Developmental Therapeutic Program (DTP)

Strong Intellectual Core

  • Knowledgeable about industrial pharmacy, drug discovery and development Vision to understand the big picture
  • Skilled in solving technical issues that impact the development program and regulatory strategy Expertise that covers the entire development path
  • Proficient with formulations, clinical manufacturing, FDA interactions, IND and ANDA filings, and clinical development

What We Do

  • Formulation development
  • Analytical methods development
  • Regulatory and drug development
  • cGMP clinical supply manufacturing
  • Commercial manufacturing of specialty pharmaceuticals
  • Strategic consulting services

Why Clients Come to IriSys

  • We have decades of pharmaceutical R&D expertise
  • We meet or exceed client timelines
  • We offer direct communication with project scientists
  • We have a client focus that accommodates change