IRISYS | San Diego CDMO: Pharma Development & GMP Manufacturing

Expertise and compliance with GMP regulations for the manufacturing of pharmaceutical formulations for clinical trials and specialty pharmaceutical products.

Strategic Consulting

Drug development guidance and regulatory strategies at all stages of the FDA drug approval process, including special assistance for international clients.

We Deliver Innovative Solutions

Clinical Supply Manufacturing

Clinical trials manufacturing services for numerous dosage forms.

Specialty Commercial Manufacturing

Registration batches, formulations for rare diseases and orphan drugs.

Difficult to Develop Products

New formulations that are tailored to a drug’s physical and chemical characteristics.

Novel Drug Delivery Technologies

Formulations for new chemical entities and ANDA/generic products.

Analytical Support Services

Development and validation of analytical methods.

IND & ANDA Filings

Preparation and submission of regulatory filings to the FDA including CMC section.

IRISYS serves as the R&D, manufacturing, regulatory and strategic partner for innovative biopharma companies as they move compounds from early research through the clinical trials required for regulatory approvals. We provide unparalleled attention to our clients, specialized services, and direct access to senior-level experts.