A pre-commercial pharmaceutical company with a single asset was launching their product in both the U.S. and European markets.
As the pharmaceutical company was preparing to launch their first product, the chief compliance officer unexpectedly had to go out on leave. This sudden change and vacancy in a key position presented a challenge for the company, as they were concerned about how to implement a global healthcare compliance program while simultaneously bringing their first product to market.
Baker Tilly supported the client by stepping in as their interterm chief compliance officer. During this time, Baker Tilly helped implement and execute different aspects of their healthcare compliance program, including policy and procedure development, training content development and delivery, business needs assessment reviews for HCP consulting arrangements, and more.
With the help of Baker Tilly acting as the chief compliance officer function, the pharmaceutical company was able to successfully launch their product in both the U.S. and Europe. In addition, they were able to successfully maintain compliance with applicable laws and regulations and the company has not been the subject of an investigation and has not received any inquiries from regulatory enforcement agencies.