Case Studies
Proven Results at Scale
See how we've helped the world's leading pharmaceutical companies solve complex quality and compliance challenges with measurable outcomes.
Quality Excellence: Achieving Right-First-Time Manufacturing Through QbD & Investigations
A leading global pharmaceutical company was experiencing recurring batch failures and high deviation rates across multiple manufacturing sites. Previous quality improvement initiatives had yielded inconsistent results, and regulatory scrutiny was increasing.
Knowledge & Risk Management Platform Deployment Across Global Network
A fast-growing biotech was experiencing significant knowledge loss during technology transfers from R&D to commercial manufacturing and between sites. Critical process knowledge existed only in the minds of key personnel, creating unacceptable risk.
Mock FDA Inspection & Compliance Risk Mitigation for Critical Site
With a major FDA inspection imminent, a top-5 pharmaceutical manufacturer engaged Light Pharma to conduct a rigorous mock inspection and develop a prioritized risk mitigation plan. The site had not been inspected in 4 years and had undergone significant changes.
Root Cause Investigation: Resolving Chronic OOS Results with Multivariate Analysis
A specialty pharmaceutical company struggled to identify the root cause behind a persistent series of out-of-specification (OOS) batch results. Previous internal investigations had failed to substantiate a root cause, putting product supply at risk.
Analytical Method Lifecycle Management: Ppk Improvement from 0.8 to 1.4
A pharmaceutical company identified analytical methods with significant variation relative to specifications (Ppk = 0.8) that had not yet caused out-of-specification results but posed growing risk of future OOS events and regulatory citations.
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