Kymanox was approached by a product sponsor for an emergency use combination product looking to fill a role in their quality department. Instead of getting one person to fill the role, Kymanox provided several qualified resources to work together as a part of their team. Two years later, this company now has a dedicated Kymanox Project Manager, a Site Head of Quality, and teams of Device and Chemistry, Manufacturing, and Controls (CMC) Subject Matter Experts (SMEs) to help with ongoing clinical programs and the commercial launch of their product. Kymanox differentiates ourselves by applying a team approach rather than providing only one person to support the client’s need.

Challenge

A company was looking to backfill a role in their quality department because their Site Head of Quality was on the brink of retirement. They needed support for the commercial launch of their product and quality oversight for their operations

Solution

Kymanox®provided multiple resources who could provide a synergistic approach to filling the organizational gaps in the company and assist with their needs beyond Quality (Product Development, Project Management, and Technical Services).

Results

Two years after the initial ask, Kymanox resources are working closely with this company's team to help them prepare for their commercial launch.