Allison Fulton is a partner in the Intellectual Property Practice Group in the firm’s Washington, D.C. office. Allison advises pharmaceutical, medical device, dietary supplement and cosmetic companies in a variety of civil and regulatory matters. Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR).
She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and Warning Letters, remediating data integrity issues and handling adverse events and medical device reports (MDR). She works with companies throughout the world on GMP and QSR compliance, including the U.S., China, Europe and South America.
Allison also has led numerous internal investigations involving allegations of off-label promotion and healthcare fraud and abuse. Her practice includes advising clients on compliance issues, drafting healthcare compliance policies and procedures, and developing content for and conducting compliance training programs.
Examples of Allison’s engagements include:
- Advised U.S. based, pharmaceutical contract manufacturer on data integrity issues following an inspection at an international facility, and worked with FDA Office of Compliance to achieve successful result;
- Assisted global medical device company in preparing for FDA inspection at an international facility, responding to FDA Form 483s at US sites, and developing remediation work plans;
- Advised U.S. aseptic pharmaceutical manufacturer in preparing for inspections by U.S. and Australian regulatory authorities;
- Worked with dietary supplement company to implement GMP programs and prepare for and respond to FDA and state inspections; and
- Drafted healthcare compliance policies and procedures and related training for pharmaceutical and medical device companies.
Prior to her legal career, she worked as a software engineer where she specialized in software validation. Allison earned her law degree from the University of Texas School of Law, where she was the managing editor of the Texas Intellectual Property Law Journal. She received her B.S. in Industrial Engineering from Northwestern University. Allison devotes her pro bono practice to assisting veterans obtain benefits for service-connected disabilities.
Education:
- J.D., The University of Texas School of Law, 2005, with honors
- B.A., Northwestern University, 1999
Admissions : District of Columbia
Cost
Rate : $$$
