Streamline Your Combination Product Program

Our consultants support you in defining the right technical and user requirements early in the development process. Emendo helps map out intended use indications or effects and incorporate human factors engineering. 

Additionally, we align product specifications with the constituent parts of your pharmaceutical formulation. Whether you’re working with prefilled syringes, autoinjectors, or other delivery devices. We keep product functionality and patient usability at the core of the design. 

We provide support in building robust design history files and writing documentation that complies with product standards, such as ISO 11608 and ISO 11040. The team designs and documents the necessary design verification and stability studies to justify shelf-life. Statistical subject matter expertise is also offered to justify sample sizes and analyze test results.

Thanks to our product and methodology knowledge (ISO 14971), we also conduct and give technical inputs to risk assessments throughout the design control process.

Our regulatory experts help you navigate the complex frameworks that govern drug-device combination products. To ensure compliance, regulatory pathways are aligned with the primary mode of action, guided by internationally recognized guidelines (e.g., EU MDR; FDA CFR; other XX ), and to receive approval according to the specific markets.

Furthermore, by defining the correct classification – whether a single entity or cross-labeled combination product – early on, we minimize risk and prevent late-stage surprises.

From early project planning to execution and lifecycle support, we act as an extension of your team. More specifically, our team manages complex dependencies across Pharma and MedTech and coordinates third-party vendors. 

As a result, this ensures your combination product project stays on track, on budget, and fully compliant.