Are you ready to start your PCM journey? From executive education to business strategy we can help. Our solutions enable design and implementation of PCM processes.
Business Strategy
- Executive Leadership Education
- Program/Platform Identification
- Financial Analysis
- Investment/Capital Planning
Program Management
- Overall program and/or Individual Project Management
- Schedule Development and Cost Tracking
- Internal and External Reporting
Equipment / Facilities Design
- Equipment Selection
- User Requirements Development and Design Support
- Vendor Evaluation, Selection and Management
- Vendor Follow up and FAT (Facility Acceptance Testing)
- Installation SAT (Site Acceptance Testing) and Qualification
- Post SAT Modification
Control Strategy/PAT/RTR
- Product Selection, PAT Integration
- Material and Equipment Characterization
- Integrated Model Development including RTD, PAT, and IPCs
- Design Space Studies
- Sampling Strategy, Rejection Strategy
- Accuracy Testing
- Data Preparation for RTR
Regulatory Support
- Regulatory Strategy
- Regulatory Plan
- Health Authority Interface, Meeting Management and Communication
- Documentation Creation
- Health authority communication
- Publishing and Submission Support