Amin Wasserman Gurnani LLP

Managing Partner: Ivan Wasserman Email: [email protected]

Number of Professionals: 25 and growing

Firm Overview:

Amin Wasserman Gurnani is one of the nation's leading regulatory, intellectual property and litigation law firms focused on the food, beverage, dietary supplement, pharmaceutical, cosmetic and medical device industries. The firm acts as a key strategic partner to companies in these dynamic sectors, offering far more than basic legal counsel. It guides clients through the entire lifecycle of their products, from development, clinical trials and regulatory approvals, to trademarks and patents, to supply and manufacturing agreements, to import issues, to creating effective and compliant advertising and labeling, and defense against challengers including consumer class actions.

The Team:

The firm's attorneys and other professionals are very diverse but share a common dedication to its clients and passion for the industries it serves. Many have scientific backgrounds, including degrees in Food Science and Human Nutrition, Chemistry, Biomedical Engineering, Pharmacy, Pharmacology, and Biomedical Science. They have government experience such as at the FDA and at the United States Attorney’s Office, and have received numerous awards and recognitions including Best Lawyers in America, Lexology Client Choice and Super Lawyers.

Main Areas of Practice:

Food, Beverage, Dietary Supplements & Cosmetics:

The firm provides industry leading, comprehensive guidance to ensure products comply with all aspects of FDA, USDA and state regulations, including: ingredient reviews; GRAS/NDI analyses and submissions; label and website reviews; claim substantiation; FDA facility registration; GMP and FSMA requirements; responding to Warning Letters, recalls, inspections and Prop 65.

Contact: Abhishek Gurnani Email: [email protected]

Medical Devices:

The firm's medical device team represents companies on all aspects of medical device legal and regulatory matters, including Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s), and Investigational Device Exemption (IDE) Applications; the Quality System Regulation (QSR); Medical Device Reporting (MDR) Regulations, labeling, advertising, inspections, recalls and more.

Contact: Neil O’Flaherty Email: [email protected]

Advertising:

The team not only brings a creative approach to creating compliant campaigns, but also when investigations or disputes arise, it regularly represents companies in proceedings before the Federal Trade Commission (FTC), the National Advertising Division (NAD), State Attorneys General, and in consumer class action and Lanham Act litigation.

Contact: Lauren Aronson Email: [email protected]

Litigation:

With offices in Chicago and the class action capital California, we have former Assistant United States Attorneys, sought-after class action defense lawyers, and commercial litigators versed in supply chain and other commercial and intellectual property disputes. Our multidisciplinary approach – combining regulatory and scientific savvy with expertise in litigation – has proven value. We draw upon our collective understanding of the food and drug industries and matters specific to labeling, advertising, intellectual property, contracts, and supply chain to provide a prompt assessment of issues and craft a pragmatic, focused strategy to achieve effective results.

Contact: Matthew Orr

Email: [email protected]

Due Diligence:

The firm works with corporate law firms and investment companies conducting due diligence on targets before acquisitions or investments. Whether evaluating regulatory compliance or intellectual property portfolios, the firm provides timely and efficient reviews to meet client needs.

Contact: Rakesh Amin Email: [email protected]

Hemp & CBD:

The firm's Hemp and CBD practice is at the forefront of these growing sectors, and provides many of the country’s leading ingredient suppliers, brands and retailers with up-to-the-minute, strategic advice on the rapidly changing state and federal regulations.

Contact: Rend Al-Mondhiry Email: [email protected]

Customs & Imports:

This team is experienced in legal services pertaining to U.S. Customs such as audits and entry procedures, classifications of tariffs, marking and labeling, protests and prior disclosures. The team also assists with detentions, forfeitures, seizures and other enforcement actions.

Contact: Abhishek Gurnani Email:[email protected]

Trademark & Brand Protection:

The firm prepares and prosecutes trademark applications before the U.S. Patent and Trademark Office, draft licensing agreements and litigate before the Trademark Trial and Appeal Board and federal courts. It also assists clients in obtaining and enforcing trademark rights around the world, and advise on gray-market and counterfeit goods issues.

Contact: Ryan Kaiser Email: [email protected]

Patents:

The firm prepares and files United States and foreign patent applications; provide opinion letters related to freedom-to-operate, non-infringement and validity/invalidity; provide strategic IP counseling related to infringement risk analysis, mitigation, patent design-around and maintenance and review of IP Portfolios.

Contact: Peter Paredes Email: [email protected]

Contracts Agreements:

The firm work with clients to develop sales, manufacturing, distribution, and supplier agreements, with special focus on the protections unique to FDA-regulated businesses; confidentiality and non-disclosure agreements; non-compete and informed consent agreements; and IP license agreements.

Contact: Abhishek Gurnani Email: [email protected]