WASHINGTON, March 10, 2021 /PRNewswire/ -- Laurie
Clarke, JD, MPP joins TSG Consulting as 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, to help clients deliver FDA-compliant,
innovative medical devices across the patient care continuum. TSG
Consulting and Sagentia are both Science Group companies.
Erin Tesch, MD of TSG Consulting
in North America, 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."
Rob Morgan, PhD, Managing Partner
Medical, Sagentia adds: "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."
Laurie Clarke 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."
Laurie received her law degree from Stanford University after obtaining a Masters in
Public Policy (MPP) with a concentration in health policy from
Harvard University and an AB cum
laude from Smith College. 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
books under the pen name "Carolyn
Keene." As an FDA partner, Laurie helped expand the medical
device practices at three top-ranked law firms – Hogan &
Hartson, King & Spalding LLP, and Jones
Day. 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.
About TSG Consulting
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.
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 – 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.
TSG Consulting is a Science Group company.
www.tsgconsulting.com
About Sagentia
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.
www.sagentia.com
About Science Group
- Science Group plc (AIM: SAG) is a science-led advisory and
product development organization. The Group has three
divisions:
- R&D Consultancy: providing advisory, applied science and
product development services cross-sector helping clients derive
maximum return on their R&D investments.
- Regulatory & Compliance: helping clients in highly
regulated markets to launch, market and defend products
internationally, navigating the frequently complex and fragmented
regulatory ecosystems.
- Frontier Smart Technologies: designing and manufacturing chips
and modules for the DAB/DAB+ radio markets with 80% market share
(excluding the automotive market).
With more than 400 employees worldwide, primarily scientists and
engineers, and speaking more than 30 languages collectively, the
Group has R&D centres in Cambridge and Epsom with more than ten
additional offices in Europe,
Asia and North America.
www.sciencegroup.com
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