The People Behind the Counsel

Deepa Moti is a Regulatory Affairs Specialist with a Biomedical Engineering background and a Master of Science in Regulatory Affairs spanning drugs, biologics, and medical devices from discovery through post-market utilization. That foundation has given her a working command of pharmaceutical and biologics regulatory pathways alongside her device-focused expertise, resulting in a genuinely cross-sector perspective she brings to every engagement. Deepa began her career as a Biomedical Engineer in a hospital setting, working hands-on with medical devices and compliance documentation, before going on to gain experience with Johnson & Johnson MedTech, Medtronic, and a regulatory consulting firm, exposure that has given her a grounded, practical understanding of regulatory affairs, quality systems, and product lifecycle.

Deepa's approach is defined by precision and foresight: rather than simply processing submissions, she builds the regulatory intelligence and strategy that facilitates getting a product into the market.

Deepa's regulatory work spans the complete medical device lifecycle: 510(k) premarket notifications, Q-Submissions, PMA support, and EU MDR technical documentation, with depth in Software as a Medical Device (SaMD) and AI/ML-enabled device regulation. This includes developing regulatory strategy and market intelligence to determine appropriate product classification and the optimal pathway to market, drawing on her work assessing frameworks across the U.S., EU, LATAM, and other international markets, including ISO 13485, MDSAP, and FDA Breakthrough Device pathways. She also developed an FDA cybersecurity submission template aligned with Section 524B of the Federal Food, Drug, and Cosmetic Act, reflecting her attention to the latest and most consequential FDA guidance. Beyond pre-market work, she applies regulatory and international-language requirements to labeling and instructions for use (IFU), ensuring alignment with FDA requirements and EU MDR General Safety and Performance Requirements (GSPR) across diverse regulatory jurisdictions, which is essential work as products move into new and unfamiliar markets. She also supports sustained post-market compliance through deficiency tracking systems, adverse event and vigilance reporting, and technical documentation practices designed to catch recurring compliance risk before it becomes a costly problem.

Deepa's cross-sector depth is reflected in her peer-reviewed publication examining the regulatory landscape of Software as a Medical Device (SaMD) compliance across FDA, EU MDR, and international frameworks. It's emblematic of something she cares about deeply: staying genuinely engaged with the evolving edges of regulatory science, from AI/ML-enabled devices to global harmonization efforts.

Deepa approaches each engagement with precision, discipline, and a firm commitment to guiding clients through complex and evolving regulatory requirements translating technical and legal complexity into clear, defensible pathways to market.

Aaliyah Alexander is a Law Clerk at The FDA Law Solution, where she focuses on FDA regulatory and compliance matters involving food, cosmetics, dietary supplements, hemp-derived products, and cannabinoid regulation. She has developed a particular interest in the rapidly evolving regulatory landscape surrounding hemp, THC, CBD, and other cannabinoid-containing products, with an emphasis on helping businesses understand how emerging federal and state requirements affect product development, marketing, and distribution.

Recent legislative and regulatory developments, including Public Law 119-37 and evolving federal and state hemp regulations, have drawn Aaliyah's attention to the intersection of FDA regulation, state cannabis laws, and consumer product compliance. As a result, she has taken a proactive approach to helping clients understand new regulatory requirements through practical, business-focused guidance while identifying potential compliance risks before they become enforcement issues.

Aaliyah has begun assisting with questions concerning the impact of these regulatory changes on product formulation, labeling, marketing claims, interstate distribution, retail sales, and the classification of hemp-derived consumer products. She believes the evolving regulatory framework will have its greatest impact on manufacturers, brand owners, distributors, and retailers operating in the hemp, CBD, THC, dietary supplement, cosmetic, and functional food industries as both federal and state oversight continue to expand.

In addition, Aaliyah has a particular interest in FDA “General Wellness” policies and helps clients evaluate when products and promotional claims may fall within the FDA's General Wellness guidance and when they may instead trigger regulation as drugs, dietary supplements, cosmetics, or medical devices. She works with clients to assess product claims, advertising language, labeling, and marketing strategies to reduce regulatory risk while positioning products for commercial success.

Aaliyah is committed to providing practical, forward-looking regulatory guidance that enables businesses to anticipate regulatory change, maintain compliance, and confidently bring innovative consumer products to market.