Pharma
Pharmaceutical Excipient Qualification Program
Streamlining the excipient qualification process for a generic pharmaceutical company, reducing time-to-market through pre-validated supply.
Problem statement
A generic pharma company faced long lead times and documentation gaps when qualifying new excipients across multiple dosage forms and sites.
Our approach
We built a standardized excipient portfolio with harmonized documentation, assisted with risk assessments, and aligned supply across global manufacturing locations.
Results
- Reduced average excipient qualification timelines by several months.
- Improved regulatory readiness with complete, consistent documentation packages.
- Simplified global sourcing by consolidating onto a smaller, well-controlled supplier base.