CHALLENGE
A large pharmaceutical company preparing to launch a new cancer therapy faced a critical regulatory challenge. The company’s advertising agency, while experienced in promotional materials, lacked the specialized knowledge required to prepare Group Purchasing Organization (GPO) emails – a key component of the launch communication strategy. These emails must be submitted to the FDA for pre-clearance review before they can be used. Without this submission and approval process in place, the company risked being unable to deploy GPO communications at launch, placing the new therapy at a significant competitive disadvantage in the marketplace.
SOLUTIONS
To close the knowledge gap and maintain launch readiness, CMK Select deployed an experienced Project Manager to collaborate directly with the client and their advertising agency. Working cross-functionally with internal stakeholders, the CMK Project Manager documented and curated the end-to-end process for creating, reviewing, and approving GPO emails. The result was an 8-step detailed guide outlining every stage of development, from content creation to internal review and FDA submission. CMK facilitated training and knowledge transfer to ensure the agency understood and could execute the process correctly and efficiently.
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8step end-to-end GPO email process created and documented
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100%of required GPO emails prepared and submitted for FDA pre-clearance
IMPACT & VALUE REALIZED
The impact was immediate and measurable. With CMK’s structured process in place, the advertising agency successfully prepared and submitted all required GPO emails for FDA pre-clearance within the tight launch timeline. This proactive approach ensured that GPO communications were ready and approved in time for product launch, allowing the company to maintain its market momentum and competitive position in the oncology space.