A top 10 global pharmaceutical company sought to outsource CMC regulatory submissions as they lacked the internal capacity to achieve all of the necessary work.
The client required support to it’s internal post-approval CMC team in the production of submission packages to global markets, for a portfolio of marketed products.
The work included EU variations and US supplements with accompanying Quality Overall Summaries (QOS).
Kinapse worked closely with client team leads from initiation of a product change request to delivery of the published submission.
A blended onshore / offshore Kinapse team utilised client specific databases and formats to deliver the work.
Integral to the Kinapse process was a comprehensive CMC expert review which ensured the quality of submissions.
The presence of an onshore project manager provided additional quality assurance and client liaison.
A rapid and flexible response team, allowing the client to focus on internal priorities.
Kinapse Regulatory CMC experts ensure high quality of submissions.
Engagement is ongoing.