Light Pharma: Enabling Operational Excellence and Regulatory Compliance
The pharmaceutical industry discovers, develops, manufactures and delivers drugs to patients across the world. The global industry is regulated and profitable and this is expected to continue to be so into the future. The United States (US) is one of the largest consumers of pharmaceutical products and India one of the largest exporters to the US. This market is regulated by the US Food and Drug Administration (FDA). Successful FDA approvals of drugs and inspections of facilities are important to pharmaceutical companies, the U.S. FDA and the U.S. patient. Light Pharma believes that the launch of the FDA 21st Century Quality Initiative in 2002 provided a major opportunity for both the regulator and the regulated industry to transform them to significantly improve pharmaceutical quality. Light Pharma and their personnel have been closely associated with this initiative through interactions with FDA, industry and leading academic institutions. Over the past fifteen years since the launch of this initiative, Light Pharma’s consulting and technology solutions in quality, risk and knowledge management such as PI quality by design and root cause investigation tools have enabled some of the most significant transformations in the way medicines are made at several of the leading pharmaceutical companies.Transforming the Pharmaceutical Industry
Light Pharma personnel have played a leadership role in enabling Process Analytical Technology (PAT), Quality Risk Management (QRM) and Knowledge Management (KM) across the industry.
These approaches are means to achieve regulatory compliance, accelerate time to market and/or enhance overall effectiveness and efficiency of product development and manufacture. The company provides consulting and technology solutions along these lines. Before and during the technical implementation of quality improvement programs, Light Pharma facilitates the development of case studies that demonstrate the value of operational excellence, risk management, knowledge management, quality by design, and other transformation initiatives. These business cases help pharmaceutical companies identify, clarify, prioritize, focus and communicate opportunities for improvement.
Light Pharma’s past focus has been on pharmaceutical developers and manufacturers in the U.S. and European regions. Going forward,the company intends to focus increasingly on working with similar companies in the Asian market and, in particular, the Indian market. The company has already begun to engage with a number of leading pharmaceutical companies in India that are reaching out to Light Pharma’s consulting and technology solutions. This is expected to amplify over the next five years.
Light Pharma personnel have played a leadership role in enabling Process Analytical Technology (PAT), Quality Risk Management (QRM) and Knowledge Management (KM) across the industry
Light Pharma’s past focus has been on pharmaceutical developers and manufacturers in the U.S. and European regions. Going forward,the company intends to focus increasingly on working with similar companies in the Asian market and, in particular, the Indian market. The company has already begun to engage with a number of leading pharmaceutical companies in India that are reaching out to Light Pharma’s consulting and technology solutions. This is expected to amplify over the next five years.
