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COMING SOON LEARN MORE Sterile Liquid Injectable Vial Production and Lyophilization new equipment NEW LEARN MORE Aseptic Filling Capabilities equipment NEW LEARN MORE Fully Automated System to Manufacture Sterile Ophthalmics

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.

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Our Experts Are Here For You…

Preclinical Development

Pre-formulation. Analytical method development. Formulation development.

IND Filing

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

Phase 1 & 2 Clinical Trials

GMP clinical materials. Analytical method qualification. Formulation revision.

Phase 3 Clinical Trials

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

NDA Support

Full scale registration batches. CMC section drafting.

Specialty Pharma Manufacturing

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

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Welcome to Societal™
Recro has a new name. And, with it, a renewed sense of what we can accomplish with our partners to expedite the delivery of life-changing pharmaceuticals to patients. Together, we are truly Bringing Science To Society. You will soon be able to explore our vision with the upcoming launch of our new website.