Our Technologies
Our technologies are at the leading edge and based on decades of experience in life sciences and healthcare. Working with leading organizations across industry, government (e.g. FDA), academia and non-profits, our technologies have enabled powerful transformation. Our technologies are applicable across the lifecycle and involve:
Artificial Intelligence/Machine Learning (AI/ML) tools have been developed for use over the lifecycle to accelerate availability of medicine to patients and regulatory compliance. For example. applications are available for use to support continued process verification, root cause analysis, product quality review, management review and development. Additional applications are being worked on every day!
Management review is a key management responsibility. Our technology enables use of quality metrics, key performance indicators and quality maturity assessments across the lifecycle to support review of the systems and enable its improvement to accelerate adoption of the best-practices of ICH Q10 and Q11.
There is a need for the monitoring of process performance and product quality to assess whether a state of control has been maintained. Our technology enables a lifecycle approach to process validation that starts with process design and development and technology transfer and builds on that into commercial manufacturing to accelerate adoption of the best-practices of ICH Q10 and Q11.
There is a need for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, nonconformance's, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. Our technology enables enhancement of investigation by leveraging risk and knowledge management and data analytics and AI/ML to accelerate adoption of the best-practices of ICH Q10 and Q11.
Effective change management can provide a high degree of assurance there are no unintended consequences of the change. Our technology enables assessment of risk associated with proposed change and impact analysis to support agility, flexibility and continuous improvement and the acceleration of adoption of the best-practices of ICH Q10, Q11 and Q12.
Management review should provide assurance that process performance and product quality are managed over the lifecycle. Our technology enables product quality review during stages of design and development and technology transfer and commercial manufacturing to accelerate adoption of the best-practices of ICH Q10 and Q11.
Quality risk management provides a systematic process for the assessment, control, communication, and review of risks to the quality of the medicines across their product lifecycles. Our technology enables you to digitize your quality risk management activities across design and development, technology transfer and commercial manufacturing to accelerate adoption of the best-practices of ICH Q8, Q9, Q10, Q11, Q12.
Knowledge management is a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Our technology enables you to digitize your knowledge management activities across design and development, technology transfer and commercial manufacturing to accelerate adoption of the best-practices of ICH Q8, Q9, Q10, Q11, Q12.
Our technology enablers support incorporation of regulatory intelligence into development, technology transfer and commercial manufacturing activities to accelerate and sustain regulatory CMC approvals and GMP compliance. Critical CMC and GMP assessment activities are digitized and incorporate both learning from past regulatory queries and inspections and regulatory guidance expectations of best-practices and quality maturity.
A large amount of data and information still resides in documents, spreadsheets and inaccessible source systems. Our data digitization and organization tools make them accessible for use across the organization.
A large amount of knowledge still resides in documents, spreadsheets and inaccessible source systems. Our knowledge digitization and organization tools make them accessible for use across the organization.
We leverage our CMMI Level 5 Maturity processes to provide technology services for life sciences and healthcare. These include quality engineering, product development and lifecycle management of technologies.
Light Pharma's Services leverage years of experience, focus and insight.
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Light Pharma is a consulting and technology company on a mission to help transform the way medicine is made.
Light Pharma Private Limited
DHI Innovations Center
Arekere, Bannerghatta Road
Bangalore, India , 560076
Contact : +91 9686455720