PDMA Compliance Services - 21 CFR
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
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.
Compliance and risk
assessments to provide overall picture of compliance in light of the
PDMA and current industry good practices.
Analyses to provide line item identification of potential remediation
points from both business processes and information systems.
development of an entire quality management system or simply review and
update existing policies and procedures.
business processes and recommendation of enhancements in conjunction
with compliance assessment.
developing processes and evaluating tools for sample accountability from
sample requests, allocation, distribution, shipment, and Representative
monitoring Representative inventory and reconciliation, as well as in
development of metrics for monitoring system performance.
developing processes and evaluating tools used in the wholesale
distribution of product; warehouse management systems, facilities,
additional software, and regulatory compliance issues.
development and implementation of processes and systems focused on Sales
Force Automation and the recording of call data and sample drop data.
won’t just tell you what’s wrong – we’ll help you get it right!