IRISYS

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.

Our Experts Are Here For You…

Pre-formulation. Analytical method development. Formulation development.

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

GMP 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.