The Prescription Drug Marketing Act (PDMA) is being rigorously enforced by the FDA and the Department of Justice. Billions of dollars in fines have already been levied against major, world renowned pharmaceutical manufacturers. Violating PDMA could even land executives, managers and/or pharmaceutical sales representatives in jail for as long as 10 years.

Valoit, Inc. helps mitigate the risks of violations, prioritizing risks in order to develop a specific project and drive your activities to a state of compliance and control.

Our goal is to provide assistance in the implementation of organizational processes in compliance with the PDMA and industry good practices that facilitate maintaining compliance. In the area of electronic records and electronic signatures we help maintain validated systems.

SERVICES INCLUDE:

• Compliance and risk assessments to provide overall picture of compliance in light of the PDMA and current industry good practices. 
• Detailed GAP Analyses to provide line item identification of potential remediation points from both business processes and information systems. 
• Assistance in development of an entire quality management system or simply review and update existing policies and procedures. 
• Evaluation of business processes and recommendation of enhancements in conjunction with compliance assessment. 
• Assistance in developing processes and evaluating tools for sample accountability from sample requests, allocation, distribution, shipment, and Representative receipt. 
• Assistance in monitoring Representative inventory and reconciliation, as well as in development of metrics for monitoring system performance. 
• Assistance in developing processes and evaluating tools used in the wholesale distribution of product; warehouse management systems, facilities, additional software, and regulatory compliance issues.
• Assistance in development and implementation of processes and systems focused on Sales Force Automation and the recording of call data and sample drop data.

We won’t just tell you what’s wrong – we’ll help you get it right!