RegRx Consulting, LLC is a select group of highly skilled regulatory affairs professionals with over 50 years of combined experience with the US FDA (CDER/CBER) and other regulatory authorities.
We provide consulting services and solutions to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs.
Roberta ("Robbie") Tucker and Elizabeth ("Liz") Fenna are partners of RegRx Consulting, LLC.
Robbie started her career in 1981 assuming increasing roles and responsibilities in large international pharma and small start-up companies (Parke-Davis, Hoechst, Astra USA, Muro Asta Medica). Robbie has submitted numerous IND's, NDA's and overseen approvals of a number of new chemical entities. Robbie has extensive experience dealing with FDA as well as management experience. Her last position was as Senior Vice President of Critical Therapeutics, where two products were approved during the first review cycle.
Liz started her career in 1982 as an analytical chemist and worked her way into Quality Assurance for a large generic drug manufacturing facility. After about 3 years in QA, Liz moved into regulatory affairs, first in generics, then in non-NCE NDAs for extended-release dosage forms, and finally joined a large PhRMA company (Astra now AstraZeneca) in 1991. After 10 years of progressively responsible regulatory positions, she left large PhRMA to join Clinquest, a small consulting firm, where she maintained the regulatory affairs franchise. In 2004, she joined Critical Therapeutics, a start-up company, to obtain approval of an NDA.
In 2008, after working together for 10 years at various companies, Liz and Robbie decided to form RegRx Consulting, LLC where they continue to collaborate to bring their customers high quality, diverse experience and expertise.
Endocrine & Metabolism
Local Anesthetics/Pain Control
Antiviral and anti-infectives