Life Sciences

What are the issues: The life sciences industry today, increasingly emphasizes investment in innovative technologies.  They involve new and developing regulatory frameworks. With anti-bribery anti-corruption (ABAC), economic sanctions and export controls enforcement on the rise, pharmaceutical firms are under growing pressure to comply with an ever-increasing array of laws and regulations. Given the broad range of jurisdictions in which multinational pharmaceutical firms operate, maintaining compliance has become very challenging.

As the life sciences industry has become more competitive, reports on corruption have increased dramatically over the last few years. Many pharma and medical device companies have been scrutinized for allegedly violating corruption laws and charged with serious and hugely expensive criminal and civil actions. Even a seemingly working compliance program in place is often not sufficient. Companies must guard against becoming complacent as regulations continuously change. Pharmaceutical firms in particular must constantly monitor their internal procedures as well as those of related third parties to prevent risk of losing millions in revenue and seriously damaging their reputation.

How we assist:  Companies engaged in life sciences products and services often can benefit from expert advice to enable them to reach business goals while remaining in regulatory compliance.  Givon Advisors has extensive experience in the life sciences area.  Let us put our knowledge and expertise to work for you.

We help you undertake a review of many activities, which occur daily within the pharmaceutical industry, and which pose substantial compliance risks. For example, in ensuring  its anti-corruption compliance, we structure and guide your review of:

  • Fee-for-service payments to HCPs.
  • Educational grants and sponsorships.
  • Research grants.
  • Clinical research and publication of clinical trials.
  • Charitable donations and community support activities.
  • Travel and entertainment expenses.
  • Consultant meetings and use of consultants.
  • Employment of agents.
  • Support for third-party medical meetings and conferences.
  • Company-sponsored educational and promotional meetings.
  • Gifts or other items of value provided to HCPs.