Pharmaceutical manufacturing processes and process technology is at the very core of Colorado Lagniappe’s expertise. Our specialized knowledge of pharmaceutical manufacturing is focused in the following areas:
Early-Stage Development
- Ensure Quality Target Product Profile achieves desired Target Product Profile
- Select and/or qualify CRO’s, CMO’s, and CDMO’s; coordinate and provide oversight of contract organizations to ensure timely completion of deliverables.
- Characterize and evaluate critical process parameters (CPPs) & critical-to-quality (CtQ) attributes.
- Author risk design/process assessment documentation (dFMEA/pFMEAs) and traceability matrices for product input requirements.
- Author, review, and execution of documentation to support equipment qualification for manufacturing processes.
- Equipment URS
- SOPs & Work Instructions
- IQ/OQ/PQ
- Author development reports and validation protocols/reports
- Gather project data & metrics to facilitate the budgeting process for the development, transfer, or implementation of technology.
Late-Stage Development
- Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing
- Select and/or qualify CDMO’s and CMO’s; coordinate and provide oversight of contract organizations to ensure timely completion of deliverables.
- Operations management: establishing project timelines & deliverables to ensure manufacturing readiness.
- Scale-up and building of commercial supply chain; achieving launch readiness.
- Process assessment at CMOs/CDMOs to determine opportunities for optimization.