Pharma Regulations

Is your Pharma supply chain buttoned down?

It’s a new environment. Cost pressures coupled with regulatory compliance are forcing Pharma and Life Science companies to become more transparent, efficient and nimble. And keeping the public safe in an age of global pharmaceutical sourcing requires improved safety testing standards, greater industry oversight of contract manufacturers and suppliers, and expanded enforcement capabilities.  The dilemma is that the typical Pharma supply chain was built for a different time.

The Foreign Corrupt Practices Act, Food and Drug Administration Amendments Act, E-Pedigree requirements, Current Good Manufacturing Practices, EU Pharma Directive and Food and Safety Enhancement Act of 2009 are just a few of the ever expanding list of regulatory compliance now required of Pharma and Life Science companies.  Previous guidance specified that companies are ultimately responsible for ensuring that processes are in place with regard to outsourced activities. Going forward not only is the company ultimately responsible but also held accountable. The fines are staggering, the brand damage can be irreparable and the new rules now allow executives themselves to be prosecuted and barred from the industry--even if they have left the company where compliance issues were uncovered.

It is estimated that a pharmaceutical product recall can exceed $20 billion in damages. Because the financial risk is so great, Pharma and Life Science companies need to successfully button down and manage the integrity of their supply chain.

Aravo can help

Aravo helps your procurement, legal and finance teams to easily and quickly manage your exposure to regulated/mandated compliance requirements, as well as lower your cost of compliance. It provides a consistent due diligence process across your extended enterprise – managing supplier policy, credentials and compliance documentation in a single, globally available repository.

Aravo can help establish and implement processes that can determine both the suitability and competency of a vendor. The processes include the establishment of an approved procedures checklist regarding prequalifying, auditing, monitoring, selecting and requalifying suppliers at established time intervals. Companies using Aravo can also establish and maintain approved supplier lists, quality agreements, and storage for vendor qualification documentation. With a deep technology bench, Aravo can help Pharma and Life Science companies meet the demands of compliance challenges today and into the future.