Leading Pharmaceutical Regulatory Experts

A post-graduate in Pharmaceutics from Mumbai University with over 25 years of Regulatory Affairs experience across leading Pharmaceutical and Medical Device organizations. Managing Regulatory affairs is my core strength and in addition I have a rich experience in handling quality compliance, clinical trials, patents and scientific information. In 2011 I started with my own venture - Regulatory Solutions India for providing Regulatory Affairs consultancy with a motto to build 'bright bRight strategies' to organizations . Regulatory Solutions India provides RA services to the Medical Device/Pharmaceutical/ Cosmetic Industry, which include:1) Regulatory Strategy Development 2) Consultancy services from application submission to Product Approvals/ Licenses comprising:

Aldo Vidinha is an internationally experienced leader with more than 18 years of expertise in the pharmaceutical industry, specializing in Engineering, Validation & Qualification, GMP Compliance, Quality Assurance, and Manufacturing. Throughout his career, he has successfully led and delivered the construction, start-up, commissioning, qualification, and validation of multiple pharmaceutical manufacturing facilities across Europe, the USA, Australia, and China. As a Project Lead, Aldo has managed capital expenditure projects valued at up to €18 million for major international pharmaceutical players. His proven track record demonstrates his ability to navigate complex technical and regulatory challenges while delivering projects on time and to the highest quality standards. Beyond his technical expertise, Aldo is a highly driven and motivated leader known for his strategic thinking and ability to build high-performance teams. He brings a unique combination of deep industry knowledge and strong business acumen, enabling him to contribute at both executive and governance levels. His areas of professional interest include engineering innovation, sustainability, Industry 4.0 and 5.0, and the advancement of pharmaceutical validation and qualification practices. With a passion for shaping the future of pharmaceutical engineering, Aldo continues to make a significant impact on the industry through leadership, thought partnership, and consulting.

I’m a lifesciences compliance strategist with a passion for building real-world, right-sized programs in fast-moving environments. With deep experience in pharma and medtech, I specialize in translating regulatory complexity into practical, actionable frameworks. I’ve spent 7+ years navigating the gray areas of compliance—from training physicians on industry expectations to building startup programs from the ground up. I believe compliance should be ethical, functional, and human-centered—and that culture is built through clarity, storytelling, and respect, not fear. Outside of policy and audits, I speak regularly on startup compliance and love turning “boring” topics into memorable moments. I'm here to connect, create, and contribute.

I am a practicing clinical pharmacist with over 20 years of experience and a graduate of St. John’s University School of Pharmacy in Queens, NY. With an undergraduate background in compounding and natural medicine, I have served in various capacities across the pharmaceutical industry before founding Fusion Medical Care in Scottsdale, AZ. My career is defined by my dedication to a balanced approach between natural and allopathic medicine, a passion that led me to develop a complete wellness center housing multiple integrative practitioners. Beyond my foundational education, I have advanced my specialized training through the Professional Compounding Centers of America and am a Certified Diplomate of the American Board of Anti-Aging Health Practitioners. I believe that my role as a pharmacist offers the perfect opportunity to fuse naturopathic and allopathic care, acting as a dedicated advocate for my patients' pharmacological and wellness needs. My mission is to empower patients to look and feel amazing by following my core philosophy: "Let your food be your medicine, your kitchen be your pharmacy, and your lifestyle be your doctor". My innovative approach to healthcare has earned me national recognition, including an honor in Marquis Who’s Who and a featured interview with VoyagePhoenix highlighting my journey and the mission behind Fusion Medical Care.

Carmen M Lerga is a cosmetic scientist and regulatory expert with three decades of experience shaping successful beauty and skincare products for global brands including Dove, Rexona, Axe, Isdin, Covonia, Oilatum, Cetraben, Hedrin, Nizoral, and INEOS. She leads Olalla Consulting, a consultancy recognised for scientific rigor, clarity, and deep knowledge of EU and UK cosmetic regulation. Her background spans formulation development, global regulatory leadership, ingredient safety assessment, and the creation of clear and balanced scientific narratives for brands and manufacturers. Carmen specialises in well aging science, neuro skin communication, and microbiome stability, bringing an evidence based perspective to emerging trends and product innovation. Journalists value her ability to explain complex topics in a straightforward and non promotional way. She offers grounded insights into regulatory changes, ingredient safety, formulation strategy, and the science behind modern beauty innovation. Her work supports companies seeking transparent, compliant, and science led product development across Europe and beyond.

Eric Epstein is a former senior federal agency counsel with more than three decades of experience drafting, implementing, and defending major federal legislation and regulations. Before retiring from federal service, he served as Senior Policy Counsel at the U.S. Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, where he was a principal advisor to executive leadership, the Attorney General, and White House officials on complex regulatory, legislative, and national enforcement matters. Over a 32-year career, he drafted and helped implement major federal firearms and explosives regulations and legislation, including the firearms trafficking provisions of the Bipartisan Safer Communities Act and ATF’s “Ghost Gun Rule,” which was later upheld by the United States Supreme Court. He spent 15 years in the field working alongside ATF agents and investigators on criminal and regulatory cases, providing firsthand operational insight into how federal laws are enforced in practice. He also represented ATF before industry leaders at trade conferences and executive meetings, giving him direct experience with how federal regulatory policy affects manufacturers, importers, retailers, and other regulated entities. Throughout his career, he authored dozens of federal regulations and rulings, advised members of Congress on statutory language, and worked closely with the U.S. Solicitor General in Supreme Court litigation. His work shaped administrative records, national enforcement policy, and compliance strategy across regulated industries. He is a recipient of the Distinguished Presidential Rank Award, the highest honor for career federal employees, as well as the Attorney General’s Distinguished Service Award. Mr. Epstein is the founder and CEO of Commentari, an AI-based platform that helps individuals and organizations analyze legislation and agency rulemakings and draft substantive public comments grounded in the Administrative Procedure Act. His work focuses on regulatory and legislative strategy, public comment impact, and litigation risk in federal policymaking. He provides commentary on federal rulemaking, legislative drafting, administrative law, regulatory litigation risk, firearms and explosives legislation and regulation, and how federal agencies develop, defend, and enforce major policy decisions. He is available to provide clear and practical insight into complex regulatory and legislative developments. He is based in the Washington, D.C. area.

I am a strategic marketing manager with over 7 years of experience in medical devices and pharmaceuticals, focusing on developing and executing launch strategies and promotional activities. I have a background in brand and product management, with experience in developing value propositions and managing product portfolios. I also have extensive experience managing stakeholder relationships, leading cross-functional teams, and creating data-driven commercial launch plans

Deniz Baynal is the Founder of DetoxCapsuleShop.com, a premium online shop specializing in high-quality herbal detox teas and botanical capsules. With a passion for natural wellness, Deniz curates blends featuring science-supported ingredients like green tea, guarana, goji berry, L-carnitine, and fennel to support gentle detoxification, metabolism, digestion, and energy without harsh effects. Drawing from extensive research into herbal traditions and modern wellness practices, Deniz focuses on safe, effective formulas for daily use. DetoxCapsuleShop products are designed for those seeking clean, plant-based support for bloating relief, natural cleansing, and overall vitality. As an advocate for transparent, non-GMO herbal solutions, Deniz shares insights on proper detox tea usage, ingredient benefits, and combining teas with capsules for optimal results. Available for expert commentary on herbal detox methods, natural supplements, wellness trends, and safe cleansing routines.

- Development of perfume compositions in compliance with IFRA protocols; - Development and adjustment of perfume formulations; - Development of fragrances for candles, soaps, cleaning products, and aroma diffusers; - Three-stage organoleptic production control; - Work with leading companies: BASF, Takasago, Firmenich, IFF, KAE, SOS, Kusado; - Consulting on finished product quality, fragrance adjustments, and the selection of new fragrance compositions; - Chemical synthesis of fragrances at the production facility.

I am a healthcare compliance executive and the originator of Stark Watch, a generative AI platform built to monitor physician contracts for strict adherence to the Stark Law and the Anti-Kickback Statute (AKS). As a Compliance Vice President at a $4B health system, I navigate the complexities of healthcare regulations, hospital-physician financial relationships, and corporate ethics on a daily basis. Ensuring physician compensation compliance is one of the most resource-intensive challenges for modern hospitals. Historically, auditing these agreements for Fair Market Value (FMV) and commercial reasonableness required hundreds of hours of manual review. Recognizing this bottleneck, I architected Stark Watch to transform healthcare regulatory technology (RegTech). Our compliance software leverages generative AI to automate contract analysis, detect potential AKS violations, and track compensation tied to Designated Health Services (DHS). By turning a reactive auditing process into a proactive, technology-driven workflow, Stark Watch empowers health systems to protect their bottom line, avoid severe regulatory penalties, and maintain the highest ethical standards in their physician partnerships. With a deep commitment to safeguarding healthcare integrity, I hold triple certifications: Certified in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), and Certified in Healthcare Privacy Compliance (CHPC). My current focus is bridging the gap between stringent regulatory frameworks and cutting-edge technology. I actively use artificial intelligence to streamline compliance operations, ensure alignment with OIG safe harbors, and mitigate AKS and Stark Law risks in complex contracting environments. My professional focus centers on providing actionable insights into the practical application of AI in healthcare administration, the evolving landscape of the Stark Law and Anti-Kickback Statute, and the future of healthcare compliance software. Whether analyzing recent Department of Justice enforcement trends or designing algorithms to parse complex medical directorship agreements, my goal is to make healthcare compliance more efficient, accurate, and accessible.

Dr. Akshaya Srikanth Bhagavathula is an Associate Professor of Epidemiology at North Dakota State University, internationally recognized for his pioneering work at the intersection of digital epidemiology, pharmacovigilance, and artificial intelligence. His research harnesses advanced statistical modeling and AI to track and predict health behaviors, medication safety, and disease patterns in real time—bridging traditional epidemiology with next-generation digital health analytics. Dr. Bhagavathula has published more than 250 peer-reviewed articles in leading journals, including Annals of Epidemiology, JAMA Network Open, and Lancet Digital Health. His work has been widely cited and featured in major media outlets such as The New York Times, where he discussed the real-world safety of GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy, Mounjaro). Recognized among the Stanford–Elsevier Top 2% of Scientists (2019–2024) and elected as a Fellow of the American College of Epidemiology, Dr. Bhagavathula is known for translating complex data into actionable insights that shape public health policy and clinical practice. His ongoing projects include NIH- and NSF-aligned initiatives on AI-powered overdose forecasting, digital twins for public health, and real-world drug safety surveillance using explainable machine learning. With a decade of experience spanning more than two dozen countries and collaborations with organizations such as WHO, USAID, and UNICEF, Dr. Bhagavathula brings a global, data-driven, and human-centered approach to solving modern health crises.

Balaji Enterprises is an Indian manufacturer and solution provider specializing in anti-counterfeit packaging technologies, with a strong focus on hologram tapes, hologram stickers, void labels, and QR-enabled security labels. With over a decade of hands-on experience, the company works closely with rice mills, exporters, pharmaceutical manufacturers, agro-commodity brands, and FMCG companies to protect product integrity across domestic and international supply chains. Balaji Enterprises is widely known for its hologram bag sealing tapes used on 25 kg and 50 kg woven PP, BOPP, and laminated bags, especially in the rice and agricultural export industry. These tapes are designed to prevent tampering, refilling, and brand misuse, offering visible authentication at the point of distribution. Beyond manufacturing, Balaji advises brands on practical, cost-effective packaging security strategies, helping businesses transition from basic stitching methods to advanced sealing solutions. The company actively educates industry stakeholders on counterfeiting risks, packaging vulnerabilities, and compliance-driven security adoption, making it a trusted voice for journalists covering product security, packaging innovation, counterfeit prevention, and supply chain protection.

Bill Hall is the Cofounder and CEO of OurRecords, where he leverages over 30+years of experience in the technology and compliance sectors to create innovative solutions that streamline regulatory compliance management. His unique blend of technical expertise and deep knowledge of industry regulations has been pivotal in developing tools that simplify complex compliance processes, earning OurRecords a reputation as a trusted industry leader. Bill holds a Computer Science Degree from University of Louisiana Lafayette and has previously held key executive leadership roles in healthcare and other industries, where he developed a keen understanding of the challenges faced by organizations in highly regulated industries. His commitment to excellence and forward-thinking approach continue to drive OurRecords' growth and success.

I entered the hemp space at the very beginning when there were almost no guardrails, no industry playbook, and very few operators who truly understood what it took to formulate something that actually worked. Hemp-derived flower and hemp wellness products were barely a category. What existed was largely untested, poorly sourced, and built around novelty rather than need. From day one, our approach was different purpose before profit, formulation before marketing, and a deep belief that every formulation should serve a real purpose. At JustKana, I oversee product development, quality control, and sourcing from the ground up. That means building relationships directly with small-batch organic hemp farms, evaluating raw material quality before it ever reaches a formulation stage, and ensuring every finished product meets both our internal standards and third-party lab verification. My work lives at the intersection of plant science and consumer wellness. I specialize in cannabinoid formulation for real therapeutic outcomes sleep support, chronic pain relief, anxiety management, and inflammation using full-spectrum hemp extracts that preserve the natural compound profile of the plant rather than isolating single ingredients. Over the years I've helped develop products that have made a measurable difference for thousands of people veterans managing PTSD, seniors dealing with chronic joint pain, and individuals looking to replace pharmaceutical sleep aids with something cleaner and plant-derived. That direct connection to consumer outcomes shapes every formulation decision I make. I understand the hemp supply chain from soil to finished product cultivation practices, extraction methods, cannabinoid and terpene profiles, and how sourcing decisions downstream directly impact what a customer experiences. In a space flooded with white-labeled, mass-produced products, that depth of knowledge is rare.

Representative for UPGRAD'D Laboratories Naomi is a Marketing Executive at UPGRAD'D Laboratories, a UK-based specialist in skincare and cosmetic manufacturing. She serves as the primary point of contact for the laboratory’s multi-disciplinary team, which includes an experienced cosmetic formulator, physicists specialising in Phototherapy (Red Light Therapy) and a small business owner. In addition to providing manufacturing services for external clients, UPGRAD'D Laboratories develops and manages a portfolio of science-led house brands: Photology: Red light-approved skincare designed to support the skin and enhance the results of LED therapy. PULP: A skincare range utilising upcycled ingredients alongside clinical research to bridge the gap between sustainability and efficacy. 28 Day Skin: A British, ingredient-led brand rooted in evidence-based formulation. Naomi provides journalists and editors with direct access to technical expertise and brand insights. She is available to coordinate expert commentary, collaborative content, and product samples for review across the UPGRAD'D portfolio.

Research Credentials: - Senior Teaching Fellow, Bond University Fellow at Centre for Space, Cyberspace and Data Law - Fellow at Institute of Space Law and Ethics, For All Moonkind - Affiliate at Royal Aeronautical Society - Previous research at European Space Agency and United Nations Office of Outer Space Affairs Gregory Radisic is a lawyer (Barrister & Solicitor) specializing in outer space law, regulatory law, emerging technologies, and securities law. He has extensive experience completing complex legal and policy projects for senior leadership at international organizations and governments, including at the United Nations and European Space Agency. Gregory has been recognized for his extensive advocacy and pro bono work in public international law, receiving the King Charles II Coronation Medal from the Government of Canada for his "outstanding achievement abroad that brings credit to Canada”. In 2025, he was named Top 30 under 30 by the Alberta Council for Global Cooperation. Guided by a commitment to advancing equitable and effective governance of space, Gregory's research aims to drive positive change at the evolving frontier of space law. Gregory teaches at the Bond University Faculty of Law and is a Fellow of the Centre for Space, Cyberspace & Data Law (CSCDL), an Australian research centre studying the legal and governance challenges at the intersection of space, cyberspace, and data. Gregory is also a Fellow at the For All Moonkind Institute of Space Law and Ethics, where he has delivered presentations before the United Nations Committee on the Peaceful Uses of Outer Space on the protection of lunar heritage sites. He has published and presented extensively on emerging space law issues including lunar heritage protection, asteroid resource utilization, constitutional protections for dark skies, orbital regulation, and the intersection of securities law with technological innovation. Gregory is also an Affiliate at the Royal Aeronautical Society, Executive at Young Diplomats of Canada, and Member of the International Astronautical Federation. Gregory is currently completing a Doctor of Philosophy (PhD) in Law candidate at Bond University, where his research focuses on dispute resolution and regulatory frameworks for conflicts among public and private space actors.

RERA360 is a specialized real estate compliance and advisory firm focused exclusively on the Real Estate (Regulation and Development) Act, 2016 (RERA). The organization supports builders, developers, real estate agents, and homebuyers by simplifying complex regulatory requirements and ensuring end-to-end compliance across real estate projects. With a strong understanding of RERA frameworks, state authority processes, and evolving regulatory guidelines, RERA360 delivers structured, accurate, and timely compliance solutions. Its services cover project registration, quarterly and annual filings, documentation management, authority coordination, and advisory support—helping stakeholders operate with transparency, accountability, and legal certainty. RERA360’s approach is built on clarity, process discipline, and practical execution. By reducing compliance risks and administrative burdens, the firm enables real estate professionals to focus on project delivery, credibility, and long-term growth while remaining fully aligned with regulatory obligations. The mission of RERA360 is to strengthen trust in the real estate ecosystem by making compliance simple, accessible, and reliable—transforming regulatory requirements from obstacles into operational advantages.

Gerrid Smith has been quoted on INC.com, Forbes.com, Entrepreneur.com and CIO.com. His former company, Black Fin, was featured on the 2017 INC 5000 list at #821 and specializes in high-end digital marketing strategies. His personal specialties are in: - Google Analytics Analysis - Conversion Rate Optimization - Lead Tracking & Nurturing - Technical SEO Audits - Modern + Responsive Web Design - Legally Compliant Social Media Campaigns - PR Outreach for Link Acquisition - Video/YouTube Promotion - Inbound Marketing & Strategy - Sponsorship Opportunity Analysis - Funnel Strategy and Implementation - Content Marketing

Santosh Yerasuri is a Supply chain and Logistics Leader specializing in risk Management, Transportation strategy and operational finance with teh Speciality chemicals and Aerospace industry. He currently serves in a critical Supply chain leadership role at a global speciality chemicals company, where he leads cross functional initiatives and manages high impact logistics and risk mitiagation programs. Santosh is a senior Member of the IEEE and an active contributor to the Engineering, Power systems, Vehicle Technology and Logistics communinity. He has served as Grand Judge for Society for Science fairs and reviews technical papers for IEEE conferences like ITEC, CIACON and international engineering forums. He has Authored several peer reviewed publications indexed in Scopus, Web of Science, and authored multiple books on Supply chain, logistics and Transportation focusing on Transportation systems, power systems engineering and operational Optimization and holds patents for Logistics Devices. Santosh holds an MS in Manufacturing Engineering Management from California State university Northridge, and has delivered in various Major industry supply chain conferences, With 12+ years of experience in Engineering Supply chain and Logistics his expertise spans global logistics networks, supply chain resilience, transportation risk framewoks and data-driven decision making in complex industrial environments. Through thought leadership and technical contributions, Santosh provides insights on strengthening supply chain reliability ,sustainability and strategic growth.