A Compliance Model

Our forte is helping our clients solve their current challenges where there are no simple answers, just difficult choices.

Compliance Programs are no longer “optional,” but essential to any company’s success. It’s the law. The failure to have one so can be disastrous.

The challenge is to create a program that is effective, but ”fits” each company’s unique needs. This is where the Whitelaw Compliance Group can help. It’s about creating an effective ethics and compliance program without distracting from the overall objective of providing life-saving products to patients

We provide a broad range of compliance services. Perhaps the best way of understanding what WCG provides is to think of a medical technology or pharmaceutical company as a house. We help build and maintain a solid ground floor that is up to code (compliance). As a result, it is a floor that won’t collapse into the dark, dirty, unlit basement where the bogeyman lives (fines, penalties, legal actions, etc.).

For owners wanting to venture above the first floor, we coach them on how to properly frame the second story for growth. It is about a long-term relationship. It’s about working together; finding the right balance between operating at “zero risks” and staying competitive.

Dr. Seth Whitelaw

President & CEO

Read Bio

WCG’s advantage

stems from flexibility and efficiency. Regardless of how robust the planning process is, no project approach can anticipate every eventuality. The key is being flexible enough to modify the approach gracefully and still achieve the objectives. With our unique blend of experiences (internal company/external consultant, drug/device, domestic/international), WCG can make the necessary adjustments and still meet our client’s needs.

It also makes us more efficient. More efficient in delivering the project plan, and in developing the compliance controls that effectively address our client’s Corporate Governance challenges. There simply is no substitute for hands-on experience.

The Acorn & The Oak

Many clients have asked me about the acorn and oak that are part of the Whitelaw Compliance Group logo. When I was forming the firm, my wife, a passionate and skilled gardener, asked me to describe what we did and the types of clients we wanted to serve. After listening to me describe my vision, she immediately responded, “Oh so from humble acorns, mighty oaks are born.” With that, the acorn and the oak became the logo of the Whitelaw Compliance Group.

So if you are looking for a partner to grow with you and your company, drop me a line or give us a call to discuss how we might help you with your compliance challenges.

– Dr. Seth B. Whitelaw, President & CEO

For more specific information about the compliance services we can provide for your type of company, please check out these services.

Medical Device & Technology

Pharmaceutical Compliance

Research & Development

Dr. Seth Whitelaw

President & CEO

With more than 30 years working in the life sciences industry, Dr. Whitelaw started his career in life science compliance in 1993, when he became the Compliance Coordinator for C.R. Bard, Inc. Present since the inception of life science compliance, his career has encompassed a wide variety of roles from in-house compliance officer with C.R. Bard, Inc., SmithKline Beecham NA, GlaxoSmithKline, and Misonix, Inc., to industry consultant with Deloitte and now his own firm, the Whitelaw Compliance Group.

A frequent author and speaker, he also serves as the editor of the Policy & Medicine Compliance Update (formerly the Life Science Compliance Update), and a law professor at Mitchell Hamline School of Law where he currently teaches students about health care compliance.

A graduate of Bowdoin College (A.B.), Washington & Lee Law School (J.D.), George Washington Law School (LL.M.) and Widener University School of Law (S.J.D.), Dr. Whitelaw also is a former Food and Drug Law Institute (FDLI) fellow, and worked as an intern for the FDA’s Office of Chief Counsel.

PUBLICATIONS

Whitelaw, et al., Drug Pricing – The Next Compliance Waterloo, 44 Mitchell Hamline L. Rev. (2018 Forthcoming). Available at SSRN: https://ssrn.com/abstract=3127733

Whitelaw, et al., A Bright Future or Unfulfilled Promise – An Update on Biosimilars and Their Prospects for Contributing to Meaningful Cost Reduction, Life Science Compliance Update, Vol. 4.3 (Mar. 2018).

“One Purpose to Rule Them All – A Resounding ‘Yes’ According to the District Court in U.S. ex rel. Cairns,” Life Science Compliance Update, Vol. 4.2 (Feb. 2018).

“On a Collision Course – FDA Clinical Investigator Disclosure and Open Payments,” Life Science Compliance Update, Vol. 2.9 (Sep. 2016).

“The Board of Directors’ Role in Pharmaceutical Compliance,” Pharmaceutical Compliance Monitor (Dec. 10, 2012).

“How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?”, Food and Drug Law Institute Policy Forum (Jun. 2011).

“Evaluating IRB’s and Their Roles,” 16 Food, Drug, Cosmetic and Medical Device Law Digest

“Proposition 65 v. Industry: David Against Goliath or a Misled Public Run Amok?,” 44 Food Drug Cosmetic Law Journal 677

REPRESENTATIVE SPEAKING ENGAGEMENTS

Guest lecturer at Temple University, Ursinus College and Medical Devices Section, Food and Drug Law, Rutgers-Camden Law School

Mitchell Hamline School of Law, National Speaker Series (Oct. 2016)

Mitchell Hamline’s Health Law Institute Symposium – Hot Topics in Healthcare Compliance (2018)

CBI 2nd Annual Drug Pricing Transparency Conference (2018)

CBI Annual Pharmaceutical Compliance Congress (multiple years)

Pharmaceutical Regulatory and Compliance Congress (multiple years)

Food and Drug Law Institute Advertising and Promotion Conference (multiple years)