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

IriSys has developed and validated analytical methods for hundreds of products.

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.

New Chemical Entity (NCE) Development

Pre-formulation. Analytical method development. Formulation development.

Pre-IND meeting with FDA. Full IND with CMC section drafting. eCTD conversion.

cGMP clinical materials. Analytical method qualification. Formulation revision.

Large volume clinical materials. Process validation. Analytical method validation.

Full scale registration batches. CMC section drafting.

Solid oral dosage forms and liquids. Process improvement and validation.