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, the European Union, 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.
- Provided counsel and 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 and closure systems. Assisted in the submission of Drug Master Files (DMFs) and provided support in establishing compliance with United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) requirements
- Performed regulatory review of food-contact materials to assess compliance with the European Union Plastics Regulation (EU) No. 10/2011 and applicable EU Member State legislation