Rachael Pontikes
USA Guide 2024
Band 1 : Healthcare: Pharmaceutical/Medical Products Regulatory
Email address
[email protected]Contact number
+1 312 207 2857Share profile
Band 1
About
Provided by Rachael Pontikes
Practice Areas
Rachael, a partner in Reed Smiths’ Life Sciences Health Industry Group, represents coalitions of compounding pharmacies and outsourcing facilities to challenge FDA, state regulators, or other regulatory bodies on critical issues defining the industry. Rachael also advises life sciences and health care clients on the full range of health care regulations impacting companies operating in this industry.
She is quick to understand and support her clients’ business perspectives, allowing her to formulate business solutions that fit into the regulatory framework of the industry.
Rachael has notable strength in representing health care facilities in high-stakes federal Food and Drug Administration, Drug Enforcement Administration, and state agency investigations and related litigation, as well as acting as regulatory counsel for large-scale, high-profile transactions involving major health care players in the compounding space. She provides industry tailored advice to innovative health care focused companies, such as telehealth platforms, drug distributors, physician and veterinary practices, online pharmacy and prescription management services, as well as pharmacies (commercial/retail, nuclear, compounding and institutional), hospital systems, dietary supplement manufacturers, and outsourcing facilities.
Chambers Review
USA
Rachael Pontikes is an experienced regulatory lawyer with notable strength in high-stakes FDA investigations and regulatory compliance arising from M&A.
Strengths
Provided by Chambers
"We love Rachael as she's extremely knowledgeable, tells it to us straight and is a joy to work with."
"She is a master strategist who constantly evaluates the options given the client's resources and objectives."
"We love Rachael as she's extremely knowledgeable, tells it to us straight and is a joy to work with."
"She is a master strategist who constantly evaluates the options given the client's resources and objectives."