Regulatory Project Management
By applying proven principles of cross-functional project management in a variety of expertise areas, our project managers effectively manage and achieve milestones and targets, meet or exceed project timelines, and optimize resources and communication pathways. To that end, PharmaDirections will appoint an experienced Project Manager whose background and skills best match the project requirements to oversee progress on your project, and, with a Project Leader, will serve as a direct point of contact. PharmaDirections realizes that project management is an ever--changing discipline, especially in the pharmaceutical industry. One thing remains the same: our project managers and the knowledge they bring help companies respond faster, accomplish strategic goals, and recognize return on investment.
Key Benefits
- Project Managers are highly experienced and knowledgeable in CMC process, enabling them to be fully engaged in all aspects of your project
- Taking care of relationship and alliance management frees your staff to focus on your priorities
- Risk management techniques are instituted in our processes to manage your program with control
Tools and Deliverables:
- Integrated Project Plans, Timelines, Milestones and Scheduling
- Work Breakdown Structure (see example below)
- Network Diagram (Evaluate Critical Path and Sequencing)
- Gantt Charts for Scheduling
- Cost Management
- Value Analysis
- Activity Costing
- Budget Planning, Management and Control
- Scrutinize and negotiations of Contracts
- Net Present Value Analysis
- Communications
- Planning to provide sufficient, relevant, accurate and consistent information to all the various stakeholders throughout the life of the project
- Methods, Means and Frequencies
- Foster Trust and Respect
- Project Status and Progress Reports
- Status Meetings
- Steering Committees
- Conference Calls/Videoconference