Food & Drug Archives - The BTI Consulting Group

Michael M. Gaba

tthorp — Thu, 13 Aug 2026 00:02:16 +0000

Michael Gaba provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible.

Working as an extension of each company’s legal and business teams, Michael draws on nearly 30 years of experience to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether a physician’s office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care.

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Seth H. Lundy

tthorp — Thu, 13 Aug 2026 00:01:36 +0000

Seth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades as one of the industry’s leading lawyers from sources including Chambers USA, LMG Life Sciences, Legal 500, Best Lawyers, and Super Lawyers.

Seth’s in-depth understanding of the industry allows him to work seamlessly with boards of directors, C-suite management, legal departments, compliance offices and operational divisions. He designs compliance programs; helps client to ensure that operations meet changing standards; defends clients in government investigations; performs internal audits; conducts corporate due diligence; and engages in civil, criminal and administrative litigation.

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Pamela F. Forrest

tthorp — Thu, 13 Aug 2026 00:00:41 +0000

Pamela Forrest has over 25 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.

Pamela frequently advises medical device manufacturers on responses to FDA enforcement actions, including Form FDA-483 observations and Warning Letters. She has extensive experience working with firms to draft written responses, develop and implement corrective actions, and prepare for re-inspection.

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Evangelia C. Pelonis

tthorp — Thu, 21 Aug 2025 00:17:09 +0000

Evangelia (Eve) Pelonis assists clients on U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) matters relating to food, animal feed, food additives and ingredients, and dietary supplements. She helps clients achieve their marketing goals within the relevant legal frameworks and counsels them in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising.

Eve helps her clients with issues regarding food labeling and promotional materials; product identity statements; ingredient declarations; nutrient content claims; structure function claims; health claims; and allergen, nutrition, bioengineered, and organic labeling. Clients seek her advice regarding obtaining appropriate regulatory status for food ingredients, including preparing self-determined Generally Recognized as Safe (GRAS) positions or submitting GRAS Notices, New Dietary Ingredient Notifications (NDINs), food additive petitions (FAPs), and color additive petitions (CAPs) to FDA.

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Alan G. Minsk

tthorp — Thu, 21 Aug 2025 00:16:29 +0000

Alan is a partner, chair of the Food & Drug practice, and co-chair of the Life Sciences industry team. Alan is licensed to practice in Georgia and Washington, D.C. He works out of AGG’s Atlanta and Washington offices.

Alan is recognized by Chambers USA America’s Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013-2024. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. He serves as general counsel of The Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.

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