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Drug Company Improves the Pedigree of its Regulatory Compliance

Supply Chain in the Life Sciences industry

Abstract

A daunting compliance deadline loomed for a national cancer treatment and research network, but Deloitte Consulting LLP stepped in to help the company implement an electronic pedigree data management solution that would meet the deadline and secure their supply chain of pharmaceuticals.

The Challenge

One of the nation’s largest cancer treatment and research networks faced a regulatory compliance deadline that required them to provide pedigree papers for the drugs they distribute. This law, called the Florida Pedigree Law, seeks to protect the prescription drug supply in Florida from counterfeit, diverted, adulterated or contraband substances. Given the complexity of the regulations, the short timeframe for compliance and the high cost of non-compliance, the company solicited Deloitte Consulting LLP’s assistance in implementing an electronic pedigree data management solution within their oncology drug distribution system. This solution, called ePedigree, would secure the supply chain of pharmaceuticals distributed to their network of affiliated practices. ePedigree is more efficient, faster and more accurate than manual record keeping.

How We Helped

Deloitte Consulting practitioners, who were already assisting the client with another project, helped them understand the implications of the regulations and develop an approach that would address their needs. With a blend of regulatory knowledge, experience with the Oracle systems that would integrate with the ePedigree system and an understanding of warehousing and shipping operations, Deloitte Consulting offered the client a powerful multidisciplinary team that included a regulatory and compliance project manager, technology integration specialist and technical developers.

The Deloitte Consulting team’s services included:

  • Business process engineering
  • Regulatory compliance oversight
  • Change and communication management
  • Technology integration services

Solution

With the new technology, the company is ensuring that every drug distributed through its nationwide network is protected with an ePedigree track and trace system that documents the drug’s history in the distribution channel. As the first oncology distributor to provide electronic pedigrees (competitors are using manual processes), the company is well positioned to provide a high level of assurance to patients around the authenticity of its life-saving cancer drugs.

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