Light Pharma to help FDA coordinate review, compliance and inspection programs
This article was originally published in The Gold Sheet
Executive Summary
FDA has turned to Light Pharma Inc., the Cambridge, Mass., consulting firm headed by G.K. Raju, to help the agency develop more coordinated interactions between its three drug quality regulatory programs - review, compliance and inspection. A recent evaluation to determine the roles and responsibilities of each program under the regulatory paradigm that is emerging as part of FDA's Pharmaceutical Quality Initiative for the 21st Century "found a lack of clear roles and responsibilities and lack of clear and cohesive process steps for ensuring product quality," FDA said in a solicitation last month. Light Pharma will be following up on that assessment "to develop a seamless process between the various business units involved in product quality review, compliance and inspections with a focus on documenting roles and responsibilities at each stage of the process." The work will include running a pilot test of new standard operating procedures under various scenarios that Light Pharma will develop