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.

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.

“To get something you’ve never had, you must be willing to do something you’ve never done.” – Unknown