Expert guidance to implementing continuous manufacturing
If you are an API manufacturer, an innovative drug sponsor, generic drug developer, or CDMO considering adoption of Pharmaceutical Continuous Manufacturing (PCM), our experienced consultants are here to provide guidance and support.
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
Let’s Get Started
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
22320 Foothill Blvd. Suite 330, Hayward CA 94541
1.877.787.0177
22320 Foothill Blvd. Suite 330, Hayward CA 94541