About Colleen M. Evale

Colleen Evale advises domestic and foreign corporations on regulatory compliance with U.S. Food and Drug Administration (FDA) matters related to indirect food additives. She counsels global clients on an array of food contact materials and has extensive experience with regulatory structures in the United States (U.S.), the European Union (EU), Canada, and South America.

Colleen assists multinational companies with obtaining clearances for new substances used in contact with food through the filing of Food Contact Notifications (FCN) with FDA, as well as drafting opinion letters to establish suitable regulatory status for use of polymers, additives, inks, coatings, and adhesives in food contact applications in various jurisdictions. She counsels clients with regard to good manufacturing practice (GMP) issues relating to the manufacture of food packaging, and has experience obtaining No Objection Letters (NOL) from FDA for recycled plastic. In addition, Colleen regularly submits Drug Master Files (DMF) to FDA for materials used in drug packaging.

Colleen is a presenter at Keller and Heckman’s Annual Food Packaging Law Seminar.

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Services

Areas of Law

  • Other 6
    • 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: Strategized the submission of numerous FCN filings to FDA to establish clearances for substances used in food contact applications
    Assisted both domestic
    foreign companies in obtaining NOLs for recycled plastic
    Assisted companies with DMF submissions to FDA
    Worked on California's Proposition 65 assessments to determine whether warning language is required
    Drafted opinion letters evaluating the food contact status of various products for companies to use internally to assure compliance or for marketing purposes
    Assessed MERCOSUR compliance status of products intended for use in food contact applications
    Counseled clients on GMPs related to the manufacture of food packaging

Experience

  • Bar Admission & Memberships
    Admissions
    1997, New Jersey
    1997, Pennsylvania
    1998, District of Columbia
    Memberships

    Memberships

    •Women's Bar Association of the District of Columbia
    •American Bar Association (ABA)

  • Education & Certifications
    Law School
    Villanova University School of Law
    Class of 1997
    J.D.
    Other Education
    University of Notre Dame
    Class of 1994
    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?
    Colleen M. Evale attended Villanova University School of Law.
  • What year was this attorney's law firm established?
    Keller and Heckman LLP was established in 1962.