Kymanox provided support for the shipment qualification of a delayed release capsule product for a specialty biopharmaceutical company from its CMO in Europe. Kymanox was brought in to provide support in drafting the shipping qualification protocol, execute the protocol, and author the summary report.

Kymanox was also provided ad hoc manufacturing, technical, and supply chain support as needed and directed by the client for a child resistant package for a prescription antibiotic.

Challenge

Kymanox was brought in to draft the shipping qualification protocol, execute the protocol, and author the summary report including coordinating information collection from multiple vendors

Solution

Kymanox provided comprehensive technical project management and documentation support resources

Results

Kymanox brought in engineering resources to take full ownership of writing the qualification protocol, executing the protocol, and authoring the summary report. This freed up the client’s internal, senior level resources to focus on more high-level project work. In addition, Kymanox provided project management support and oversaw all vendor communications, ensured project tasks were completed on time, and performed site visits as directed by the client. The team who worked on this project had previous experience with the product and the vendors, so we were able to hit the ground running and execute on needs efficiently.

Kymanox also managed and supported packaging update of the product, including artwork revisions, and provided additional packaging support to compliment the main tech transfer project.