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.

Shane Hellmrich holds a BSc in Health Promotion and has spent the past 11 years independently testing and reviewing online modafinil vendors — placing personal test orders, verifying product authenticity, and documenting shipping reliability across dozens of suppliers. His work at BuyModa.net tracks over 1,300 verified customer transactions and maintains a public testing methodology that has become a trusted reference point for consumers navigating the grey-market pharmaceutical space. Shane's research covers vendor reliability scoring, product authentication, shipping logistics across international jurisdictions, and the pharmacokinetic profiles of generic modafinil products. He is regularly consulted on topics including nootropics and cognitive enhancement, online pharmacy safety and regulation, pharmaceutical sourcing and supply chain transparency, consumer protection in unregulated markets, and the real-world usage patterns of prescription cognitive enhancers. Shane is available for expert commentary, background briefings, and on-the-record quotes for journalists covering health, productivity, pharmacology, biohacking, and consumer safety.

I am a distinguished regulatory strategist with over 20 years of expertise in the pharmaceutical and medical device sectors. As the Principal Consultant at Arora 297 Consultancy, I specializes in guiding international manufacturers through the complex regulatory frameworks of Health Canada and the FDA. With a foundational background in Pharmacy and an MBA, Avinash bridges the gap between technical product specifications and high-level business strategy. His career includes pivotal roles at industry leaders in pharmqaceuitclal industry and Medical Devices industry, where I mastered the nuances of risk governance and inspection readiness. Today, I empowers clients with a "regulatory-first" mindset, ensuring not only market entry but long-term license protection and compliance integrity.

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.

Founder of MDx CRO a specialized clinical research and regulatory consultancy dedicated to the medtech IVD sector. As a seasoned consultant in clinical and regulatory affairs, I am experienced in navigating complex regulatory challenges for top IVD companies. I have the privilege of serving as an external expert for the EU Commission and having lead global regulatory projects at BSI, one of the largest Notified Bodies as an IVDR CE mark technical expert. My portfolio of satisfied clients includes renowned companies such as Biomerieux, Cepheid, Leica (Danaher), Hologic, Grifols, Abbott, Beckman Coulter, ThermoFisher Scientific, Instrumentation Laboratory (Werfen), Roche Diagnostics, Alere, and more. I am passionate about simplifying science and regulation for my clients, delivering tailored solutions that help them stay ahead of the competition. My secret to success is building relationships based on trust, expertise and kindness. My clinical background, combined with 15+ years in the IVD industry and regulatory authorities, makes me a valuable resource for clients of all sizes. Let's connect and find out how I can help you navigate the ever-evolving world of IVD and MedTech 💬

Jon Wright is a clinical pharmacist and co-founder of Arbor Vitamins, a UK-based supplement company focused on evidence-led formulation and nutrient compatibility. With a background in pharmacy and medicines optimisation, Jon specialises in how vitamins and minerals interact in the body, including absorption, nutrient competition, and supplement-medication interactions. His work focuses on translating pharmacological principles into better supplement design, including Arbor’s TRINITY multinutrient system, which separates compatible nutrients across morning, day and night to support absorption and effectiveness.

Procurement & Supply Chain Manager with 10+ years leading complex sourcing operations across infrastructure megaprojects — including Sochi 2014 Olympic Games venues and major bridge construction under strict deadlines. Managing $20M+ budgets with cross-border operations across Europe, China, and North America. Currently focused on tariff-driven sourcing strategy, AI adoption in procurement, and supply chain resilience. Credentials: CMILT (Chartered Institute of Logistics and Transport) | Board Member, CSCMP Southern California Roundtable | SDCE Pros to Know 2026 | Published in Supply Chain Management Review Available to comment on: procurement strategy, tariffs & trade disruption, AI in sourcing, project-based procurement, supply chain resilience, nearshoring

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

Founder of IngredientMD, a supplement intelligence platform powdered by most clinical data available. What's important, we communicate in language humans will understand instead. It all starts from individual ingredients instead of product name, claims, and anything else. Product is what's inside instead of what perception is being made. In our analysis of 500+ supplement products, we found 42% had at least one key ingredient below clinically studied doses. I focus on bringing evidence-based analysis to consumer supplement decisions.

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.

Irina Plakas, is a Registered Pharmacist with over 30 years of experience in healthcare and a Certified Health Coach specializing in metabolic health, behavior change, and midlife wellness. After decades working across retail, hospital, and corporate pharmacy settings, Irina developed a unique perspective on the limitations of a medication-first healthcare model. Through her coaching practice and educational work, she helps adults particularly those over 40 understand how medications, hormones, nutrition, and lifestyle interact to influence weight, energy, sleep, and long-term health. Her approach combines clinical pharmacy expertise with evidence-based health coaching and motivational interviewing to help individuals address the root causes of chronic health issues rather than simply managing symptoms. Irina is passionate about translating complex medical and metabolic science into practical, actionable strategies people can actually implement. She frequently speaks on topics such as medication-related weight gain, metabolic health, sleep optimization, behavior change, and lifestyle strategies that support long-term disease prevention. Her mission is to empower people to take ownership of their health using science-backed tools that improve energy, resilience, and quality of life.

Filiberto Amati is a marketing and commercial leader specialising in growth strategy within consumer goods, with a particular focus on beverages, food, and adjacent categories. With close to 25 years of international experience across Europe and the Americas, he has built a career at the intersection of strategy, brand development, and commercial execution. He is the founder of Amati & Associates, where he works as a growth consultant, interim executive, and advisor to companies ranging from early-stage ventures to established global players. His work centres on designing and implementing growth strategies that translate into measurable commercial outcomes, particularly in complex or underperforming market environments. Filiberto’s experience includes senior roles at companies such as Procter & Gamble, Philips, Gruppo Campari, and Disaronno, where he progressed from regional and marketing leadership positions to general management responsibilities. He has operated across more than eight countries, managing diverse teams and overseeing market entry, brand positioning, and distribution strategies at scale. As an interim CEO and senior advisor, he has been responsible for building organisations from the ground up, including establishing commercial structures, marketing functions, and innovation pipelines. His work often focuses on aligning brand strategy with route-to-market execution, ensuring that growth plans are both strategically sound and operationally viable. Beyond delivery, Filiberto contributes to the academic and professional discussion on marketing and foresight. He has published research on consumption rituals, AI in design processes, and the future of business events, reflecting a continued interest in how consumer behaviour and market structures evolve. He holds an MBA from IESE Business School and a DBA from the Polish Academy of Sciences, combining formal academic training with practical leadership experience across global markets.