About Kristen M. Ballintyn

Kristen Ballintyn counsels domestic and international clients on regulatory and compliance matters in food and drug law, with an emphasis on food additives and food contact materials. She also assists companies in obtaining regulatory clearances for food contact materials.

Kristen regularly advises domestic and foreign companies regarding regulatory requirements in a host of jurisdictions, including the United States (U.S.), the European Union (EU), Canada, Central America, South America (MERCOSUR), and China. She is well-versed in regulatory requirements applicable to new food contact materials as well as recycled materials intended for use in food contact applications.

Prior to joining Keller and Heckman, Kristen worked as the Associate Director of Chemistry, Manufacturing, and Controls (CMC) for an international pharmaceutical company. While there, she managed the manufacture, packaging, and distribution of clinical and commercial drug supplies. She also prepared New Drug Applications and Manufacturing Authorization Applications for submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Her chemistry background positions her to assist clients with the technical aspects of food and drug law matters.

Insights & In the News

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Services

Areas of Law

  • Other 7
    • Food and Drug
    • Food and Drug Packaging
    • Consumer Products and Retail
    • Food & Life Sciences
    • Packaging
    • Tobacco and E-Vapor
    • Trade Associations

Practice Details

  • Firm Information
    Position
    Counsel
    Firm Name
    Keller and Heckman LLP
  • Representative Cases & Transactions
    Cases
    Representative Matters: Provided counsel
    support in obtaining Food Contact Notifications (FCNs) for new food contact substances
    Assisted multinational plastics manufacturer in obtaining recycling no objection letters for their plastic recycling processes
    Assisted multinational chemical company in obtaining food-contact regulatory listings in the South American Common Market of the South (MERCOSUR)
    Advised plastic container manufacturers on regulatory requirements applicable to pharmaceutical packaging containers
    closure systems. Assisted in the submission of Drug Master Files (DMFs)
    provided support in establishing compliance with United States Pharmacopoeia (USP)
    European Pharmacopoeia (EP) requirements
    Performed regulatory review of food-contact materials to assess compliance with the European Union Plastics Regulation (EU) No. 10/2011
    applicable EU Member State legislation

Experience

  • Bar Admission & Memberships
    Admissions
    Maryland
    District of Columbia
    Memberships

    Membership

    •American Bar Association

  • Education & Certifications
    Law School
    University of Maryland School of Law
    Class of 2014
    J.D.
    magna cum laude
    Other Education
    University of Notre Dame
    Class of 2005
    B.S.
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Attorneys FAQs

  • How many attorneys are in this law firm?
    Keller and Heckman LLP has 80 attorneys at this location.
  • What law school did this attorney attend?
    Kristen M. Ballintyn attended University of Maryland School of Law.
  • What year was this attorney's law firm established?
    Keller and Heckman LLP was established in 1962.