The virtual pharmaceutical and biotechnology industry is unique and PharmAcumen is unique in its approach to meeting the needs of this industry.
While others try to reinvent the wheel, our experience and best-of-class practices allow us to efficiently steer your project through the manufacturing process, helping you save time and money. We achieve this by utilizing a proven process, SOP, or project plan as a quick starting point.
With our toolbox of established templates, thorough checklists and reports, we can easily plot a course designed specifically for your projects. This toolbox includes but is not limited to:
- established project plans for API and other drug formulations
- standard operating procedures (SOPs) designed for virtual pharmaceuticals
- clinical supply forecast models
- technical transfer project management tools
- shipping study processes
Even with a toolbox, we understand that an actual development program is complex and that all programs need to be customized on some level. We will tailor our approach to meet your specific needs quickly, accurately and successfully. Together, we'll help you successfully navigate the complex path of pharmaceutical development from Phase 0 through commercialization.
Some of our Representative Projects
- Design a stability program for a clinical stage virtual company that would ensure product in the clinic had appropriate dating utilizing the PharmAcumen toolbox
- Source a biotech API for a novel drug delivery system
- Perform quality audits for small and large molecule API and fill/finish sites
- Develop supply chain function and manage potential kit shortage situation utilizing best-in-practice tools
- Perform supply chain audits for virtual company to ensure best practices
- Help resolve complex deviations
- Write CMC IND sections
- Write technical reports
- Provide virtual quality assurance
- Develop vendor management/qualification program
- Design a comprehensive quality management system for a virtual biotech including risk management principles of ICH and the PharmAcumen toolbox
- Estimate Cost of Goods Sold and sensitivity model for a novel technology at a preclinical stage for presentation to potential investors
- Prepare RFP for API manufacture and test. Provide “apples to apples” matrix for cost comparison
- Design phase appropriate method qualification plan for a Phase II program
- Due diligence assessments for in-licensing of development programs
- Develop audit hosting package and FDA presentation
