BioTechLogic has provided project management leadership for virtual, mid-size and large biopharmaceutical companies that have required experience in the commercialization of a biologic or oligonucleotide compound for registration in the United States, Europe, Canada and other countries. Our experience has included project management for entire project plans, as well as management of regulatory submissions, pre-approval inspection readiness programs and process validation efforts. Our global product registration experience allows us to quickly identify risks and offer proven solutions.
BioTechLogic provides project management leadership to ensure the on-time delivery of major milestones that commence with process development completion and include process validation, global regulatory submission and pre-approval inspection readiness.
BioTechLogic’s Project Management processes are founded on the principals prescribed by the Project Management Institute (PMI), and are tailored to meet the needs of the biopharmaceutical industry.
Projects are initiated with establishment of team structures, objectives and identification of team members. BioTechLogic’s project managers and technical experts work closely with your project leaders to plan the initiative and manage the execution of all activities. We can effectively drive the process to meet every milestone. Additionally, a detailed integrated project plan and schedule (IPP&S) with critical paths is developed, reviewed with management for concurrence, and managed to achieve the milestones.
As a member of the team, BioTechLogic will plan, support and manage project meetings and drive team members to complete commitments, as well as track and expedite the completion of action items.