Not All Combination Products Are Created Equal: The Prefilled Syringe (PFS) Challenge
Prefilled syringes may seem straightforward—select a syringe, fill it with drug product, and contract out manufacturing—but in reality, PFS development is a complex endeavor. Regulatory agencies like the FDA are placing increased scrutiny on PFS-related combination products, citing a growing number of compliance issues related to design, testing, and quality systems.
The Complexity Behind the Simplicity
Effective PFS development starts with a plan: who will use the product, what it must do, where and how it will be used, and when it must perform. Unlike other combination products, PFS development doesn’t involve designing the syringe from scratch—instead, success depends on selecting the right components (barrel, needle, stopper) and integrating them into a design process that meets both user needs and drug product requirements.
This process demands cross-functional coordination across drug formulation, device integration, packaging engineering, and supply chain. Key challenges include:
- Drug-device compatibility and stability
- Human factors and usability testing
- Labeling and packaging requirements
- Risk management throughout the lifecycle
- Design verification, validation, and design transfer
- Regulatory strategy across clinical, CMC, and post-market phases
How Consult Wing Supports You
At Consult Wing, we specialize in guiding pharmaceutical and medical device teams through the unique demands of PFS combination products. Our proven framework includes:
- Defining user needs and drug product requirements
- Building integrated risk management files
- Designing compatibility and design validation testing
- Supporting technology transfer and validation with CDMOs
- Preparing regulatory documentation with aligned clinical and post-market strategies
We bring deep experience in global regulatory pathways, manufacturing scale-up, and lifecycle support, ensuring your prefilled syringe programs are compliant, reliable, and patient-focused. Please read the entire blog with a process map illustrating our end-to-end roadmap for PFS success.
Explore Our Approach
The process map below illustrates our end-to-end roadmap for PFS success.
Contact us to learn how Consult Wing can support your development teams in delivering safe, effective, and regulatory-ready combination products.
