{"id":454831,"date":"2021-03-10T09:04:07","date_gmt":"2021-03-10T14:04:07","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=454831"},"modified":"2021-03-10T09:04:07","modified_gmt":"2021-03-10T14:04:07","slug":"former-fda-lawyer-laurie-clarke-joins-tsg-consulting-to-lead-medical-device-practice","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/former-fda-lawyer-laurie-clarke-joins-tsg-consulting-to-lead-medical-device-practice\/","title":{"rendered":"Former FDA lawyer Laurie Clarke joins TSG Consulting to lead medical device practice"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n WASHINGTON<\/span>, March 10, 2021<\/span> \/PRNewswire\/ —\u00a0Laurie Clarke, JD, MPP joins TSG Consulting<\/a>\u00a0as Vice President & Principal of the company’s medical device regulatory practice. With over 25 years of experience as a Food and Drug Administration (FDA) lawyer, Laurie is a known leader in medical device regulation, from premarket submissions to FDA enforcement actions. In this newly created position, Laurie will lead TSG Consulting’s established medical device regulatory team, as well as collaborate with medical device advisory and product development colleagues at sister company Sagentia<\/a>,\u00a0to help clients deliver FDA-compliant, innovative medical devices across the patient care continuum. TSG Consulting and Sagentia are both Science Group<\/a>\u00a0companies.<\/p>\n

\n

\n
\n \"Laurie
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n
\n Erin Tesch<\/span>
\n <\/a>, MD of TSG Consulting in North America<\/span>, says: “Laurie’s vast experience allows Science Group to play a greater role in supporting clients through both product development and the required FDA approvals in the US. TSG is the only company that we are aware of that offers both medical device development and in-house FDA and EPA regulatory expertise.”<\/p>\n

\n Rob Morgan<\/span>, PhD, Managing Partner Medical, Sagentia adds:\u00a0“We work with many companies planning innovation strategies as well as designing and developing breakthrough medical products. With Laurie’s deep understanding of the FDA regulatory processes, clients now have a partner that can provide more support in new product regulation from concept to launch, so expanding the service we offer.”<\/p>\n

\n Laurie Clarke<\/span> notes: “Science Group’s thriving and dynamic medical device product development and regulatory practices attracted me to the company. At TSG, I have the rare opportunity to help clients shape their FDA regulatory strategy, including the design of their clinical studies, while their medical devices are in the early stages of development. I am excited because at that stage the client has maximum flexibility to align the device’s technology, marketing claims, and regulatory path. In addition, the client benefits from working with an integrated team. This approach promises to be cost effective as it reduces the FDA regulatory risks and thus makes it more likely our clients will obtain FDA clearance or approval to market their devices sooner.”<\/p>\n

Laurie received her law degree from Stanford University<\/span> after obtaining a Masters in Public Policy (MPP) with a concentration in health policy from Harvard University<\/span> and an AB cum laude<\/i> from Smith College<\/span>. She started her career as an FDA lawyer at Patton, Boggs and Blow. While at that firm Laurie obtained public acknowledgement that her client wrote the original Nancy Drew<\/span> books under the pen name “Carolyn Keene<\/span>.” As an FDA partner, Laurie helped expand the medical device practices at three top-ranked law firms \u2013 Hogan & Hartson, King & Spalding LLP, and Jones Day<\/span>. Most recently Laurie was Executive Vice President, Medical Devices & Combination Products at Greenleaf Health Inc., a boutique FDA consulting company. Throughout her career, Laurie has represented medical device companies ranging from small start-ups to multi-national corporations on complex regulatory matters involving a wide variety of medical devices.<\/p>\n

\n About TSG Consulting<\/b>\n <\/p>\n

TSG provides companies with high-quality regulatory and scientific consulting services. We help clients worldwide address the technical and regulatory issues in taking their products to market in multiple jurisdictions. Our scientific expertise, regulatory knowledge and understanding of local nuances enable our clients to navigate the complex and ever-changing regulatory landscape across the globe. <\/p>\n

We serve a number of key markets and industry sectors including agricultural, industrial, consumer, food and beverage, animal health, and medical. Our teams comprise scientists and regulatory experts \u2013 many of whom have previously held positions at regulatory agencies, departments and in industry. This combination of science, regulatory expertise and knowledge of how institutions and industry operate provides our clients with superior and well-rounded guidance.<\/p>\n

TSG Consulting is a Science Group company. <\/p>\n

\n www.tsgconsulting.com<\/a>\u00a0<\/p>\n

\n About Sagentia<\/b>\n <\/p>\n

Sagentia is a global science, product and technology development company. Our mission is to help companies maximise the value of their investments in R&D. We partner with clients in the medical, consumer, industrial and food & beverage sectors to help them understand the technology and market landscape, decide their future strategy, solve the complex science and technology challenges and deliver commercially successful products. Sagentia employs over 150 scientists, engineers and market experts and is a Science Group company. <\/p>\n

\n www.sagentia.com<\/a>\n <\/p>\n

\n About Science Group<\/b>\n <\/p>\n