IRISYS provides contract pharmaceutical product development and manufacturing services, specializing in formulation R&D and GMP (Good Manufacturing Practices) manufacturing of clinical trial materials and specialty pharmaceutical products. Our headquarters, laboratories and state-of- the-art manufacturing facility are located in San Diego, California.
We also offer strategic consulting related to the drug development process. Our reach extends from working with local pharmaceutical companies in San Diego to providing customized services for international clients.
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 pharma company clients’ new products to the market quickly and efficiently.
YOUR GO-TO PARTNER FOR PHARMACEUTICAL COMPANIES IN SAN DIEGO, THE US, AND AROUND THE WORLD
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.
Who we are
- Founded in 1996 in San Diego, CA 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 GMP regulations
- Experienced in bringing products to the market quickly and efficiently
- Educators for pharma companies in San Diego and elsewhere
Whom We Serve
- A wide range of pharmaceutical company clients, partners and collaborators
- Pharmaceutical companies in San Diego, California, and throughout the U.S.
- International pharmaceutical 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 development programs and regulatory strategies
- 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
- GMP clinical supply manufacturing
- Commercial manufacturing of specialty pharmaceuticals
- Strategic consulting services tailored for your needs
- Biotech and pharma companies in San Diego
- US-based companies
- International companies
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
- Our hands-on approach extends from pharmaceutical companies in San Diego to Asia and Europe