Consulting · Technology
Transforming the way medicine is made
We are on a mission to help transform the way medicine is made. Our focus is on life sciences and healthcare.
Industry
Academia / Government / Non-Profit
Measurable Impact at Scale
Our track record speaks for itself. We've helped the world's leading pharmaceutical companies transform their quality and compliance operations.
Our Services
End-to-end consulting for pharma excellence — from regulatory strategy to quality operations, we provide deep domain expertise across the pharmaceutical lifecycle.
Strategy Development
Quality strategies aligned with business objectives, regulatory expectations, and ICH guidelines.
Learn moreQuality Excellence & Sustainable Compliance
Quality systems that drive operational excellence with ICH Q10/Q11 best practices.
Learn moreRegulatory Intelligence
Real-time analysis of FDA, EMA, and global health authority expectations.
Learn moreAssessments
Mock FDA inspections, compliance risk assessments, and quality maturity evaluations.
Learn moreData Analytics and Investigations
Root cause investigations with multivariate data analysis and AI-assisted analytics.
Learn moreModernization & Technical Excellence
Data integrity, process analytical technology, and enterprise digitization.
Learn moreQuality Intelligence & Maturity
Quality maturity benchmarking with proprietary Quality Intelligence tools.
Learn moreTraining & Certification
GxP compliance, investigations methodology, quality risk management programs.
Learn moreEnabling Supply Chain Resiliency
Risk-based approaches to supplier management and continuity planning.
Learn moreOur Technologies
Light Pharma technologies are at the leading edge and based on decades of experience applicable across the pharmaceutical product lifecycle.
e-Management Review
Automate and streamline management review processes
e-Continued Process Verification
Real-time quality monitoring and statistical process control
e-Product Quality Review
Streamline annual product quality review processes
e-Quality Risk Management
Systematic identification and management of quality risks
Investigations (including CAPA)
Structured investigation and corrective/preventive action management
e-Knowledge Management
Capture and leverage organizational knowledge
e-Change Management
Controlled change processes
Regulatory Intelligence Platform
Track and respond to regulatory changes
Artificial Intelligence/Machine Learning
Advanced computational approaches for data analysis
Data Digitization & Organization
Tools to make data accessible across the organization
Knowledge Digitization & Organization
Tools to make knowledge accessible across the organization
Technology Services
Quality engineering, product development & lifecycle management
Proven Results at Scale
See how we've helped the world's leading pharmaceutical companies solve complex quality and compliance challenges with measurable outcomes.
Right-First-Time Manufacturing Through QbD & Investigations
A leading global pharmaceutical company was experiencing recurring batch failures and high deviation rates across multip...
Unified Knowledge & Risk Management Across 8 Sites
A fast-growing biotech was experiencing significant knowledge loss during technology transfers from R&D to commercial ma...
Zero Critical Findings at Subsequent FDA Inspection
With a major FDA inspection imminent, a top-5 pharmaceutical manufacturer engaged Light Pharma to conduct a rigorous moc...
100% Root Cause Substantiated for Chronic OOS
A specialty pharmaceutical company struggled to identify the root cause behind a persistent series of out-of-specificati...
Why Light Pharma
We are on a mission to help transform the way medicine is made. We achieve our mission only when you achieve yours.
Pioneering Industry Role
Light Pharma personnel have played an active and pioneering role in helping prepare the pharmaceutical and biotech industry for the 21st Century, contributing to the FDA's 21st Century Quality Initiative.
CMMI V3.0 Level 5
Assessed at the highest possible level of quality maturity under CMMI V3.0, revalidated in August 2024. One of the earlier small organizations in the world to achieve this distinction.
Technologies at the Leading Edge
Technologies developed at the leading edge and based on decades of experience in life sciences and healthcare, built collaboratively with organizations including the FDA.
Ready to Transform Your Quality Operations?
Schedule a consultation with our experts to discuss your specific challenges and discover how Light Pharma can help you achieve sustainable compliance and operational excellence.