Mary primarily concentrates her practice on counseling for-profit and not-for-profit organizations on matters involving corporate formation, risk management, contracts, audit, and compliance issues. She routinely represents providers in issues related to HIPAA, risk sharing arrangements, credentialing, reimbursement and billing issues, compliance, surveys, and rate appeals.
Mary advises clients on FDA matters involving HACCP, product recalls, regulatory compliance, retail establishments, clinical drug trials, NDAs, OTC drug issues, drug labeling and marketing, medical-device approvals, recalls, and import/export issues.