A pharmaceutical company focused on developing innovative drug products enlisted Kymanox® to create comprehensive gap assessments and recommendations reflective of current industry and regulatory expectations with regards key human factors activities, design history files, and quality management systems to ensure compliance with combination product regulation and device design controls regulation.

Kymanox also provided support for the selection of inhaler technology as well as the Contract Manufacturing Organization (CMO). The client relied on the expertise of Kymanox to evaluate commercially available Dry Powder Inhalers (DPIs) and their CMOs to select the best fit for phase II clinical trials of their two drug products.

Challenge

The client did not have the in-house expertise to develop comprehensive gap assessments for the areas needed

Solution

Kymanox provided subject matter experts with direct experience with human factors at the FDA to develop concrete and specific recommendations to remediate gaps

Results

The gap assessment conducted by Kymanox prioritized areas that the client needed to focus on addressing for the following areas: human factors testing, initial design development documentation, and essential procedures. Kymanox provided specific and concrete recommendations such that the client or anyone on picks up the Assessment can proceed with steps to remediate the gap increasing the client’s confidence in their procedures and documentation.

Kymanox provided human factors engineering insights and expertise that the client did not have in house to ensure that the gap assessment conducted followed the processes and included the elements that the FDA and notified bodies require as part of design controls and quality system regulations.