IriSys cGMP Manufacturing Services

IriSys’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials and commercial pharmaceutical products. The cGMP manufacturing team complies with IriSys’ rigorous Standard Operating Procedures and FDA Guidelines.

Commercial manufacturing requires a higher level of knowledge, performance, and regulatory scrutiny than production of clinical trial materials. IriSys has successfully met the requirements for audits conducted by regulatory authorities including recent FDA and California Food & Drug Board inspections.

IriSys provides the following cGMP manufacturing services:

Scale up from R&D to cGMP
manufacturing

Technology transfer

Drug Development Process

Formulation optimization

Clinical trial materials
manufacturing

Pharmaceutical products
manufacturing

Release testing

Certificates of Analysis

Formal stability studies
according to ICH guidelines

Commercial product
manufacturing