Our client, a medical device manufacturer specializing in global solid dose, parenteral, and cellular therapy, received a lengthy Form 483 and subsequent Warning Letter addressing the site’s aseptic manufacturing controls and practices, validation methodology, and quality systems. Upon receipt of the 483, Treximo was engaged to support the review of open CAPAs addressed during the investigation through a risk-based assessment within two months, as required by the FDA. While progressing with the quality improvement expectations of the Warning Letter, Treximo was further engaged to lead and support all improvement work streams.

Our client, an international manufacturer of parenteral drug solutions, found inconsistencies in their laboratory data suggestive of manipulation. In order to substantiate previous product releases, risk evaluation and mitigation through retrospective review was required for all products manufactured at the site. As assurance for future release, an additional data integrity plan was needed to ensure current and future employees were trained and data collection systems were properly protected, per 21 CFR Part 11.

Our client, an international facilities services firm with more than 500,000 global employees, was chosen to manage all facilities services for a global pharmaceutical client. Recognizing the challenges of moving into GMP manufacturing, the client requested GMP project management support for the transition from the previous facilities services partner to the client’s services management. In addition to manufacturing, the pharmaceutical client managed more than thirty blood donation centers that would also be integrated into the program and in need of support.

A Midwest-based pharmaceutical client needed medical writing and biometric support for a 505(b)(2) New Drug Application (NDA). The client had little NDA filing experience and needed an experienced team to develop a filing strategy, complete programming and statistical analysis, and author CTD and other documents.

An east coast based midsized pharmaceutical client required immediate data management services to take over EDC build and the creation of data transfer specifications for 10 third party vendors (Central Lab, PK, and several smartphone applications).

Projects that implement technology are challenging and require project leadership to manage a lot of moving parts, especially when external vendors are involved. Our expert Project Managers understand the complexity, uncertainty, and risks associated with implementing a large-scale enterprise technology solution.

Losing a resource in the middle of a project is frustrating for everyone. Our experienced Project Managers can be there to pick up the pieces so that your project team can keep moving toward a successful outcome.

PMO Implementation Case Study

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