Program Management and Services

IND-Enabling Program Management
The path from molecular discovery to commercialization of a human therapeutic product is resource-intensive and long. The Food and Drug Administration’s rigorous requirements are not always obvious or straightforward. Meeting these requirements demands an understanding of the nuances of adapting regulatory guidelines to a particular technology. Pharma Technology Resources provides clients the highly-valued services of definition, outsourcing, technical support and management of IND-enabling programs specific to their technologies and the associated regulatory nuances.
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Production Launch Management
A delay in the launch of product, upon FDA approval, can cost millions of dollars per day. Optimizing launch efficiency requires painstaking and time-consuming attention to details of logistics and regulatory compliance. Pharma Technology Resources’ skilled professionals can assess your company’s launch readiness and provide necessary planning, management and personnel support to help ensure timely launch.
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CRO and CMO Management
Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) selection and management are critical to a development program’s success. Collaboration with CROs and CMOs requires the commitment of the contracting company’s time and resources to maintain ongoing focus and direction. Inattention by the contracting company generally results in missed deadlines, escalating costs and lower quality deliverables.

Pharma Technology Resources provides clients with technical and project management representation for their outsourced laboratory or production requirements. PTR assists in selection of appropriate contract organizations, performing Regulatory Compliance Auditing as required, then serves as the interface between our Client company and contract organizations to establish and monitor deliverables, timelines, budgets, and methods and schedules of communication. Pharma Technology Resources also provides technical direction upon request, engaging a PTR content expert to define and direct the program through a combination of electronic data exchange and periodic site visits. PTR’s technical experts direct and manage Analytical Development, Pre-Clinical Safety Studies, Pre-clinical Efficacy Studies, Formulation Development, and Process Development.
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