We are very good at bringing forth practical, clear solutions. Compliance solutions are often too complicated and filled with compliance buzz-words. We focus on logical structure and clear direction over volume. We also look to leverage technology to automate manual approaches to reduce effort.
We are also very committed to our clients feeling like they received value in working with us. We have worked with many of our clients for many years and the bulk of our new clients come from referrals by prior clients. Our culture prides itself on the long-term view of client relationships and won’t risk long-term relationships for short-term benefits.
Additionally, we believe that we are more productive working from our office than our client’s cubicles. This has the added benefit of reducing travel expenses for our clients and lightens the travel burden on our employees. We take advantage of technologies such as web conferencing to engage with clients without the need for substantial travel. While some projects require on-site presence or live, in-person interactions with clients, many of our projects can be done almost entirely remotely, allowing our team to have greater work-life balance than many of our competitors.
We are a consulting firm focused on compliance for the life sciences sector which includes pharmaceutical, medical device and biotechnology companies. Our clients are typically the head of the Ethics & Compliance departments or one of their direct reports. We are also engaged by business functions looking to develop compliant solutions such as Finance (or Transparency), Commercial Operations, Medical Affairs, Patient Support Services, and Public Affairs.
We work with companies of various sizes and maturity of their compliance program. We have supported more than half of the Top 25 pharmaceutical manufacturers. We have also helped emerging companies launch their compliance program from scratch. Overall, since Potomac was founded, we have worked with more than 100 life science clients.
Clients engage us to help them successfully navigate complicated legal requirements such as how they can sell and market their product to doctors. While we possess a deep understanding of the regulatory environment, as consultants as opposed to lawyers, one of our key strengths is simplicity and creating solutions that are easy-to-implement for compliance professionals and easy-to-understand for life science employees. We strive to help our clients implement a more ethical, values-based culture.
Here are a few examples of projects:
A biotech company in the middle of launching its first product engages us to author its initial compliance program policies to document the rules that all employees must follow.
A large pharmaceutical company hires us to monitor educational programs led by contracted physicians and to ride with its sales force as they visit and promote their products to physicians.
A midsized medical device company asks us to develop on-demand, iPad-delivered training programs for their field force on the various regulations that impact their job.
A midsized pharmaceutical company hires us to enhance its employee Code of Conduct from a boring 20-page legalese Word document to a professionally designed, values-driven document describing how the organization wishes to conduct itself.
Since all life sciences companies are required to annually report to the US government how much they spend on physicians, a small medical device company outsources to us their entire reporting process including collecting the data, verifying its completeness, checking for inaccuracies, and ultimately reporting it to the government.
When a company is sanctioned by the government (known as a “corporate integrity agreement”), we are often brought in to help strengthen compliance protocols or provide additional staffing support as they look to implement the government’s requirements.
The work we do helps the life sciences industry conduct business ethically and legally, thereby helping to protect the reputation of the company, patients who use their product, and their shareholders.