Alexandre Gapihan

Alex provides guidance to companies on regulatory strategy, compliance issues, enforcement actions, and matters involving labeling and advertising. This encompasses advising on regulatory pathways and strategies for accelerated development, liaising with regulatory agencies, and providing guidance on conducting clinical and pre-clinical trials, research ethics, product manufacturing and quality, distribution, and the labeling, promotion, marketing, and advertising of regulated product. He assists with handling current good manufacturing practice (CGMP) inspection findings and deficiencies, such as FDA Form 483s and warning letters. Alex offers counsel on regulatory compliance for foods, dietary supplements, and cosmetic products, encompassing notices, registrations, food safety plans, corporate compliance programs, recalls, and crisis management. His expertise extends to advising on marketing, promotional launches, and social media strategies in compliance with US Federal Trade Commission (FTC) requirements. He also advises on consumer product standards and testing, including Section 15(b) notices and penalty investigations, as well as product recalls.

Prior to joining Morgan Lewis, Alexandre was an associate at another international law firm. He is a native French speaker and is conversational in Mandarin Chinese.