Commercial Production Launch Management and Support

A Pharmaceutical Client’s first product, a cardiovascular drug, was six months from projected FDA marketing approval when the Client engaged Pharma Technology Resources to assist in preparation for its commercial production launch. The Client was responsible for the supply chain, comprised of contract manufacturers, and had partnered with an established Big Pharma company to co-market the Product, which was anticipated to generate billion-dollar annual sales revenue at maturity.

Pharma Technology Resources conducted an in-depth assessment of the supply chain components and their readiness to rapidly feed the distribution centers upon notification of FDA approval. Integration of the elements had not occurred, and critical regulatory-mandated pre-approval tasks, such as process validation, had not been completed. In addition, systems to address critical areas of FDA concern — customer complaint handling and product recall—had not yet been developed and coordinated between the Client and its Big Pharma partner.

Pharma Technology Resources developed and managed a coordinated commercial production launch program. PTR filled the Client’s personnel-resource gaps with industry professionals who addressed process validation, supplier quality auditing, quality systems development, preparation for pre-approval inspection, and package engineering. Pharma Technology Resources monitored and assured progress by chairing weekly meetings of the project team—a collaboration of Client and PTR personnel—and PTR’s project leader represented production/supply on the Client’s company-wide cross-functional launch team. The Client’s product was available to wholesalers within days of notification of FDA-approval and well within industry best practice for new product launch.