Pharmaceutical & Life Sciences

Requirements

Pharmaceutical and Life Sciences companies manage vast, complex, long-term projects that involve thousands of third parties around the globe. To protect their brands and avoid regulatory penalties, these companies need to comply with Anti- Bribery and Anti-Corruption (ABAC) regulations, as well as regulations establishing controls for drug trials, business continuity, workplace safety, and information security. If third parties do not comply with FDA regulations, or audit trails are incomplete, years of work and millions, if not billions of research and development dollars can be put in jeopardy. Government agencies such as the U.S. Department of Justice (DOJ) have also recently increased their investigations of pharmaceutical companies for ABAC violations. Settlements for violations can reach hundreds of millions of dollars.

The Aravo Solution

Aravo provides third-party risk and compliance solutions to four of the world’s largest pharmaceutical companies. These companies leverage the scale and flexibility of the Aravo platform for a number of applications, including Aravo’s Anti-Bribery and Anti-Corruption configuration. Aravo ABAC includes best-practice due diligence questionnaires and processes aligned with the FCPA and UK Bribery Act, real-time risk assessments for any level of the third-party relationship, identification and mitigation of Red Flags, and pre-built integration to market-leading risk screening and intelligence solutions from Thomson Reuters, LexisNexis, Dow Jones, Polecat, and Arachnys among others.

Benefits

  • Streamline and harmonize data and processes across the third party and supply network for improved transparency, flexibility and agility
  • Eliminate risk silos and deliver a centralized ‘version of the truth’ for the extended enterprise
  • Increase third party transparency through Tier 1, 2 and beyond
  • Reduce complexity and third party administration costs
  • Expand third party networks and enter into new markets with confidence
  • Accelerate time to market
  • Reduce brand risk
  • Improve oversight with an always accessible audit trail
  • Expand to new use-cases as you harness the power of the flexible Aravo Enterprise platform

Regulations & StandardsA selection of the Regulations and Standards that impact the Pharmaceutical and Life Sciences Companies

U.S. Foreign Corrupt Practices Act (FCPA)

Forbids bribing foreign officials and mandates transparent accounting practices.

UK Bribery Act

Covers British criminal laws related to bribery and establishes penalties including imprisonment, fines, and confiscation of property.

ISO 23001

Specifies what is required for Business Continuity. ISO/IEC 27001, which specifies requirements for Information Security

ISO 14001:2015

Sets out the criteria for an environmental management system applicable to any industry.

OHFAS 18001

The international specification for occupational health and safety management systems.

UK Health & Safety at Work Act of 1974

Provides for securing the health, safety and welfare of persons at work.