Regulatory, Legal and Compliance

Regulatory
Life science companies face regulatory requirements and restrictions unique to their industry. Often times a long-term vision of the regulatory landscape is necessary to ensure that commercialization strategies are fully achieved. The pi Advisory team has deep-seated knowledge of the regulatory hurdles companies face while commercializing a product. Our team has experience working collaboratively with leadership teams on developing initial label strategies including FDA inquiries and requests.

State Licensing Requirements for Life Sciences Manufacturers/Wholesalers: prior to selling or engaging in wholesaler activity in any particular state, it is important for life sciences companies to ensure that they obtain all appropriate licensure/registration(s) to engage in such activity. The pi Advisory team can help walk clients through the often complex and highly nuanced license/registration process and ensure that the correct documentation is in place prior to beginning commercial activities.

Legal
All life sciences companies are under intense federal and state scrutiny for possible fraud and abuse. Given current governmental budgetary and oversight pressures, the number of investigations and prosecutions for violations of fraud and abuse laws, at both the federal and state level will only continue to increase. Life sciences companies operate in a world where their biggest threat is their own workforce. Recently, the DOJ and various state governmental agencies called for increased whistleblower activity. Both federal and state law incentivizes whistleblowers by providing a portion of any resulting fine to the individual whistleblower. The pi Advisory team has extensive experience advising life sciences companies on the full range of issues arising under both federal and state anti-kickback statutes, false claims acts and other federal and state fraud and abuse laws.

Compliance
pi Advisory knows that in today’s ever-changing regulatory landscape, establishing an effective compliance and ethics program is a business necessity in order to protect life sciences companies. At its core, an effective compliance program protects companies by detecting and preventing improper conduct and promoting adherence to the company’s legal and ethical obligations. In addition, an effective compliance program shows a company’s commitment to responsible conduct. While there is no “one-size-fits-all” program for every company, there are several core components that must exist to ensure compliance program effectiveness. The pi Advisory team is experienced at developing fit-for-purpose compliance solutions designed specifically for specific business needs.

 


Pi’s Expert Analysis & Knowledge Report (PEAK Report)

The pi Advisory team will provide up to a 2-hour complimentary on-site meeting designed to understand one current problem your company is facing. Based on this meeting, the pi Advisory team will provide you with its PEAK Report containing a high-level analysis of the problem and a recommendation or range of recommendations on how to resolve the problem.

Click here to learn more about how you can receive a FREE PEAK Report.