New Regulations and a Surge of Compliance Work

Problem

Due to the introduction of some new regulations affecting the life sciences industry, the Office of Ethics and Compliance of an international pharmaceutical company needed additional support in the form of subject matter experts (SMEs) to perform healthcare law compliance work in a timely manner in order to avoid facing any penalties. The international pharmaceutical company needed to add bandwidth, but could not add to their headcount.

Objective(s)

Needing flexible support to help the Office of Ethics and Compliance tackle their work, the Chief Compliance Officer of the international pharmaceutical company reached out to JURISolutions® Legal (JSL) to identify SMEs that could work on a long-term, project basis. These SMEs needed to have experience within the life sciences industry and knowledge of the regulations affecting this industry.

Solution

JSL presented the international pharmaceutical company with a team of attorneys and paralegals with the necessary expertise and experience that were all available for the long-term project. With the addition of the JSL SMEs, the international pharmaceutical company had their compliance program in place before the new regulations took effect. The international pharmaceutical company successfully avoided facing any penalties, and utilizing the JSL team of attorneys and paralegals allowed them to add bandwidth without having to add to their headcount.

Outcome

Because the international pharmaceutical company was impressed by the efficiency of the JSL team and by the quality of their work, they asked JSL for additional support in the areas of pharmacovigilance compliance, policy & standard operating procedure development, and research & clinical development. Through these first few projects, JSL gained a thorough understanding of the international pharmaceutical company’s business, and the international pharmaceutical company has continued to trust JSL to meet their temporary support needs for over 5 years.