General Project Management

We assist your critical projects at difference phase of commercialization with a dedicated Project Manager. The Project Manager oversees designated projects of yours with hands-on knowledge and can work around your schedule. They have superb organization skills and can develop strategy, including defining the goals and timeline for the project(s) they supervise. The Project Manager coordinates, documents, and assigns tasks for your project team members, and provide the team with timely support. When appropriate, he or she can manage the budget, timeline, and resources for the projects. The Project Manager also monitors problems, provides solutions, and implements changes as necessary to ensure the project timeline is followed. He or she also regularly reports the progress to the stakeholders.

Clinical Trial Management

Clinical trials such as Bioequivalence Studies would require close monitoring given their high regulatory burden and timeline sensitivity. The tasks generally involve dossier preparations for regulatory submissions, ethics committee reviews; clinical supplies preparations and shipments to meet the dosing schedules; bioanalytical testing and report writing. We provide dedicated Project Manager who has hands-on experiences and ability to work with cross-functional expertise, such as quality and clinical disciplines. We assist in avoiding simple, yet all too common, pitfalls that may otherwise result in the costly time wastes and other penalties that are inevitably associated with rejected submissions. This end-to-end service is our value to complement many start-up companies which are often limited in resources and/or regulatory knowhow.

Tech Transfer Management

When it comes to pharmaceutical technology transfer (e.g., manufacturing site change, process scale-up, or process validation), we provide a stage-gate approach specifically developed for each client’s program. The designated Project Manager asks pertinent questions to gather all the critical information that’s needed to meet the requirements of each gate. This comprehensive approach lowers the risk of costly setbacks later on in the project. A technical team is established to perform the detailed expert review of the tech transfer data and reports. The team also provides program governance, review and approval of the gates, and issue escalation. Depending on the complexity, one dedicated Project Manager will track the schedule, facilitate the meetings, and coordinate document reviews, while the other technical or quality program manager manages the activities to avoid delays with documentation and execution of technical tasks. This level of coordination enables Contract Manufacturing Organizations (CMO’s), which often are not equipped with resources or planning skillset, to be on schedule for critical delivery.