Pharmaceutival Consulting
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, 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
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
- Source a biotech API for a novel drug delivery system
- Help resolve complex deviations
- Write CMC IND sections
- Provide virtual quality assurance
- Develop vendor management/qualification program
- Due diligence assessments for in-licensing of development programs
- Develop audit hosting package and FDA presentation
