- Drafted and negotiated a variety of commercial contracts and agreements across the supply chain, ensuring compliance with regulatory requirements and managing legal risk.
- Drafted several successful FDA regulatory submissions, including Food Contact Substance Notifications (FCNs), to obtain premarket clearances for new substances.
- Counseled various clients on the compliance status of indirect food additives.
- Counseled global clients on regulatory pathways and strategic considerations for premarket approval of components intended for multiple uses, including food-contact and medical device applications.
- Advised top chemical and agribusiness companies on good manufacturing practices (GMP) issues and post-market adverse events, such as accidental adulteration or contamination scenarios.
Associate,
- Phone: +1 212 905 9031
- Email: karly.bader@alston.com
Drawing on her extensive knowledge of food and beverage regulations and in-house legal experience, Karly guides industry clients through complex litigation and compliance issues.