PLG combines a project management approach with proven subject patter expertise in the area of Regulatory Compliance. Life Sciences companies realize the need for speed when responding to regulatory enforcement- FDA 483, warning letter, or consent decree. Rapid response time requires an organized and coordinated effort by the response team to deliver a plan that can be effectively implemented to meet regulatory enforcement commitments.  

PLG applies proven subject matter expertise to response development, planning, and implementation for regulatory compliance. On-site PLG program and project leaders- with regulatory compliance subject matter expertise- manage and/or direct the activities and people associated with remediation projects through the following services:

• Organizing and facilitating the delivery of a response to regulatory enforcement
• Organizing and facilitating the development of a remediation plan that meets the commitment to the regulatory agency
• Organizing the remediation team structure to support the remediation plan
• Forecasting internal and external resource requirements to implement the remediation plan
• Applying quality system subject matter expertise including CAPA, Production and Process Controls, and Audit Preparation to project lead remediation workstreams
• Assessing and recommending industry 3^rd party expertise to supplement internal resource capabilities
• Status tracking and reporting of commitments to the regulatory agency
• Preparing the organization for audits
• Planning and facilitating the transfer of knowledge from external to internal resources to sustain improvements made

PLG enables Life Sciences companies in responding to regulatory enforcement. Our proven track record of developing, managing, and executing remediation plans helps Clients meet their regulatory agency commitments.