De-Risk Your Combination Product Development

Developing a combination product requires hitting precise milestones where the choice of a prefillable syringe (PFS) system often dictates success. Many organizations inadvertently slow their progress by managing individual PFS components separately, a process that creates a heavy burden of coordinating multiple data sets, managing various vendor relationships, and duplicating administrative efforts.

Shifting to a unified system-level approach eliminates these bottlenecks. By utilizing pre-verified system specifications and comprehensive data packages—including compatibility studies and sterilization information—developers can significantly accelerate the path to clinical fill/finish. Consolidating manufacturing controls and release specifications into a single format simplifies the regulatory process and reduces risk.