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Tony Alexander

Of Counsel
Memphis
T: 901.577.2217
F: 901.577.0758

Tony Alexander provides compliance advice concerning U.S. Food and Drug Administration (FDA) regulations that impact different points along the supply chain continuum, from raw ingredient selection for cosmetics, to the import and export of food, to the recall of implanted medical devices.

Featured Experience

Obtained a precedential opinion from the U.S. Court of Appeals, Federal Circuit, on behalf of a leader in the development of wireless networking technology.
Obtained ISO 13485 certification for a medical sterilization packaging systems company.
Developed and implemented the quality management system for an ambulation products company.

Professional Biography

Overview

Tony works with medical device, pharmaceutical, food and cosmetic manufacturers to establish, structure and manage their industry-specific good manufacturing practices (GMP), implement and audit their quality systems, and guide these clients through the International Organization for Standardization (ISO) certification and FDA and CE Mark compliance process. He also has extensive experience assisting clients in regulatory strategy design and implementation, including the preparation of regulatory submissions associated with the market clearance of their products.

As a registered patent attorney, Tony understands the interface of innovation and regulation. To this end, he focuses on client counseling in all aspects of procuring, licensing and enforcing patents and conducting freedom-to-operate and due diligence investigations. He also has significant experience in trademark, trade dress, trade secret and copyright matters. Tony's background broadly encompasses intellectual property, university technology transfer, and venture capital and regulatory compliance, with a specific emphasis in the industries regulated by the FDA.

Tony has been an adjunct professor at the University of Memphis Cecil C. Humphreys School of Law since 2012 where he teaches Food & Drug, Patent & Trademark Law. Before joining the Firm, he was a managing member of the Technology Legal Counsel for nine years and the chief legal officer and vice president of Regulatory & Quality at Alveolus Inc., a leading provider of non-vascular interventional stent technology.

Representative Matters
  • Obtained a precedential opinion from the U.S. Court of Appeals, Federal Circuit, on behalf of a leader in the development of wireless networking technology.
  • Obtained ISO 13485 certification for a medical sterilization packaging systems company.
  • Developed and implemented the quality management system for an ambulation products company.
  • Designed and implemented the quality management systems for leading cardiology, gynecology, endoscopy and blood products companies.
  • Assisted drug development company with quality agreements with API suppliers.
  • Obtained federal 510(k) clearance for certain nonvascular interventional stenting products.
  • Served as FDA counsel to a mammography center that had its certification revoked pursuant to the Mammography Quality System Act and Program.
  • Assisted with Sealed Source and Device Nuclear Material licensing issues.
Professional Honors & Activities
  • Member – American Bar Association
  • Member – American Chemical Society
  • Member – American Intellectual Property Law Association
  • Member – American Physiological Association
  • Member – American Society for Microbiology
  • Member – American Society for Quality
  • Member – Association of Corporate Counsel
  • Member – Biotechnology Industry Organization
  • Member – Financial Executives International
  • Member – Intellectual Property Owners Association
  • Member – National Association of Corporate Directors
  • Member – Society of Corporate Compliance and Ethics
  • Member – Society of Corporate Secretaries & Governance Professionals
  • Member – Board of Directors of The Consortium MMT
  • Senior Pastor – Faith Christian Church, Memphis, Tennessee (2011 – present)
  • Board Member – University of Memphis Research Foundation
FDA Experience By Industry

Medical Devices

  • New product classification (whether the product is Class 1, Class 2, Class 3)
  • Regulatory path strategy (help companies decide whether regulatory submissions are needed and whether clinical studies are required)
  • Evaluation of mobile applications and other health IT products to determine whether they are regulated by FDA
  • Prepare Investigational Device Exemption protocols
  • Prepare 510k and PMA regulatory submissions
  • Preparation of CE Mark submissions
  • Assist as independent monitor at design reviews through the duration of the development process
  • Design and implement quality systems compliant with FDA Quality System Regulations (21 CFR Part 820) and assist with ISO 13485 certification
  • Assist with FDA quality system inspections
  • Develop strategies for responding to FDA 483s and Warning Letters
  • Serve as quality system auditor for vendor qualification and ongoing surveillance
  • Formulate correction, removal and recall strategies
  • Durable medical equipment reimbursement code acquisition
  • Serve as internal quality system auditor or independent auditor of internal quality audit
  • Review and clear labeling and marketing collateral

Pharmaceuticals

  • Establishment registration and product listing
  • Adverse drug Reports
  • Labeling changes
  • Supplemental applications
  • Current Good Manufacturing Practice (cGMP) Compliance
  • Drug master files
  • Generally recognized as safe (GRAS) self-affirmations
  • GRAS affirmation petitions
  • GRAS notifications

Food

  • Food additive petitions for direct and indirect food additives (including food packaging materials)
  • Threshold of regulation exemption petitions for indirect food additives (including food packaging materials)
  • Acid/acidified food determinations and requisite registrations filings
  • Color additive petitions
  • Food contact notifications  

Cosmetics

  • Ensuring products were not classified as over the counter drugs
  • Monograph issues
  • Establishment registration and drug listing
  • Manufacturing facility qualification
  • Compliance with ISO/TC 217 internationally harmonized cosmetics standards, including ISO 22716 certification
  • Generally recognized as safe (GRAS) self-affirmations
Publications
  • "Weathering the Perfect Regulatory Storm Passing Through MedTech," Pharmaceutical Compliance Monitor (June 2014)

Awards

Industries

Education

  • University of Wisconsin – Madison, J.D., 1998
  • University of Wisconsin – Madison, M.S., 1999
  • Morehouse College, B.A., magna cum laude, 1994

Admissions

  • Tennessee, 2012
  • South Carolina, 2000
  • Wisconsin, 1998
  • U.S. Supreme Court, 2012
  • U.S. District Court for the Western District of Wisconsin, 1998
  • U.S. Patent and Trademark Office, 1998
  • U.S. Court of Appeals for the Federal Circuit, 2011

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