Leading Pharmaceutical Regulatory Experts

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 💬

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:

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.

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.

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.

Meet Dhriti Mukherjee Pipil – Trade Economist, Consultant, Speaker & Educator Dhriti Mukherjee Pipil is a Delhi NCR–based international trade economist, consultant, researcher, and speaker, specialising in trade finance, foreign trade policy, and agricultural trade. She is the Founder of Global Trade Institute (GTI), an institution focused on building export-ready professionals and businesses through practical trade education. She currently serves as a Senior Research Fellow at Indian Institute of Foreign Trade (IIFT), where her work examines India’s agricultural trade policy, export restrictions, price volatility, and supply chain dynamics. She is also an empanelled faculty with Federation of Indian Export Organisations (FIEO), delivering specialised sessions on export finance and international payment systems. Dhriti is a Leadership Member at the Women in International Trade Business Council (WIITBC) under the International Trade Council (ITC), and serves on the Economic Advisory Board of the Economic Transformation Council, contributing to trade-led policy discourse. With over a decade of experience in banking and trade finance, her expertise spans export finance, cross-border payments, foreign exchange markets, trade risk management, WTO frameworks, and emerging digital trade finance systems. She holds professional certifications from the Indian Institute of Banking & Finance (IIBF) and the International Chamber of Commerce (ICC). Her work bridges policy, practice, and pedagogy—offering consultancy in export strategy, trade finance structuring, compliance, and market entry. She actively mentors MSMEs and startups, enabling them to navigate global markets with operational clarity. Dhriti has authored peer-reviewed research in journals such as Economic & Political Weekly and The Indian Economic Journal, alongside policy contributions to The Hindu BusinessLine, Down To Earth, Policy Circle, AgroSpectrum, and global platforms including the World Trade Centre. She is a regular speaker at national and international forums, including the Economist Intelligence Unit (2025), International Trade Council (2025), WTO Chairs Programme, and Indian Economic Association. Through her work, she seeks to reduce information asymmetry in global trade and build a more inclusive, resilient, and knowledge-driven export ecosystem.

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 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.

I have a degree in pharmacy, with a specialization in cosmetics and have been working in the industry for the past decade. Firstly, as a training manager for YOUTHLAB. Portugal, and then as a content writer for Care to Beauty. Throughout the years, I've become the head of the department that handles everything related to cosmetic products, including PDP details, blog articles and product recommendations. We handle several areas that touch pharmaceutical cosmetic advice, SEO (technical and on-page), customer experience design, content creation, and e-commerce strategy.

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.

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.

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.

In my role, I meticulously oversee various clinical projects, ensuring each phase is executed with precision and in compliance with GCP standards. Core Competencies: Clinical Trials Monitoring Clinical Safety Protocols Streamlined Clinical Operations Regulatory Compliance Mastery Educational Background: MSc in Molecular Science and Nanotechnology, Louisiana Tech University MSc in Medical Genetics, MGM University of Health Sciences With a robust educational foundation and a keen eye for detail, I have successfully navigated through different therapeutic areas and regions, delivering high-quality results consistently. My journey in the realm of clinical research is driven by an insatiable curiosity and a deep-seated commitment to advancing science and practice. Let’s Connect! If you are passionate about transforming health care and improving patient lives, or if you wish to exchange insights and collaborate on projects, feel free to connect with me. Together, let’s contribute to a healthier, more understanding world for individuals navigating through challenges.

Darrion Phelps, Sr. leads with a rare blend of strategy and street-level insight. As Chief Marketing Officer of Roxford Digital, he’s built a model that bridges the gap between online visibility and local credibility. His approach aligns marketing with business development — two sides of the same growth engine. Through marketing, his team strengthens a brand’s online presence, optimizing search, content, and communication so patients can find, trust, and select a preferred provider. Through business development, he mobilizes Brand Growth Partners — professionals who serve as local ambassadors developing referral relationships, building community awareness, and turning trust into measurable growth. It’s a system designed to make healthcare brands seen online and chosen in person — blending modern marketing precision with relationship-driven connections.

James Economides, MD, FACS, is a board-certified plastic surgeon in the Washington, DC / Northern Virginia area with a practice focused on advanced facial rejuvenation, breast surgery, and body contouring. He is particularly known for deep-plane facelift and neck lift techniques, mommy makeovers, breast augmentation and revision surgery, and abdominoplasty for post-pregnancy and weight-loss patients. Dr. Economides combines high-volume, real-world clinical experience with an academic mindset—regularly teaching, lecturing, and mentoring trainees—giving him a balanced perspective on both cutting-edge techniques and long-term outcomes. He has been recognized repeatedly as a “Top Doctor” by multiple regional publications, and his practice attracts patients from across the Mid-Atlantic and beyond. In addition to surgery, Dr. Economides has a strong interest in medical aesthetics, non-surgical facial rejuvenation (Botox, fillers, biostimulatory injectables), and the responsible use of artificial intelligence in plastic surgery—from patient education and photography to ethics in before-and-after imaging. As a private practice owner, he also speaks to topics like running a modern aesthetic practice, patient experience, social media, and small-business leadership in healthcare. He is frequently sought out for clear, practical explanations of complex procedures, trends, and controversies in cosmetic surgery. His quotes are concise, patient-centered, and media-friendly, making him a reliable expert source for consumer outlets, health reporters, and business publications covering aesthetics, entrepreneurship, and innovation in medicine.

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.

As I am a medical expert for Invigor Medical, a urologist, and an MD currently completing my PhD in clinical medicine, my work bridges patient care, education, and research. I serve as a teaching assistant in surgery, where I guide and support future doctors while treating patients in everyday practice. My research focuses on oncologic urology, men’s health, and hormonal health, and I actively collaborate on international studies. Through these roles, I am dedicated to advancing evidence-based medicine, improving patient outcomes, and helping shape the future of urological care.

Pharma Clinical Formulator and Founder of EARTHLYF Clinical Skincare. Expert in the Indian exposome, barrier repair chemistry, INCI transparency, and building a D2C startup in the personal care industry.

Ryan Farmer is the founder of My Peptide Match, a consumer education site that helps people make sense of GLP-1 medications and the fast-changing peptide landscape. He focuses on simplifying complex topics—like real-world pricing, treatment pathways, sourcing differences, and what questions to ask—so readers can make more informed decisions with their clinician. Ryan tracks emerging trends across weight-loss peptides, compounding and telehealth access, and the economics that shape what consumers actually pay. He’s available to comment on GLP-1 and peptide cost comparisons, patient decision-making, and the broader market shifts driving demand. He also publishes practical reference tools, including a peptide calculator and dosage guide, to support clearer conversations between consumers and providers.

Prity Khastgir is a prominent figure in the fields of intellectual property law, technology strategy, and business innovation. Her extensive career spans over 18 years, during which she has achieved significant milestones and contributed to various sectors, particularly in intellectual property rights (IPR) and technology. Education and Training: - Selected for the Goldman Sachs 10,000 Women Executive Business Education Program, receiving a full scholarship from the Indian School of Business. This program is designed to empower women entrepreneurs with business education and leadership skills. - Founder and CEO of Tech Corp International Strategist (TCIS): Prity established TCIS to provide consultancy in intellectual property and technology strategy, catering to clients globally. - Patent Trainer at WIPO (World Intellectual Property Organization): She has been actively involved in training sessions that enhance understanding of patent laws and processes internationally. - Contributor and Journalist: Previously contributed to the China Economic Information Service, where she shares insights on technology and patents. Speaking Engagements - Recognized as an international speaker, Prity frequently addresses global conferences on the intersection of technology, law, and business within the context of Industry 4.0. She participates in ITU Regulatory Workshops focusing on Sustainable Development Goals (SDGs) and cybersecurity initiatives. Legal Expertise A registered patent attorney in India, Prity specializes in various aspects of intellectual property law, including patent drafting, prosecution, and managing complex IP portfolios for multinational corporations. Her expertise extends to sectors like pharmaceuticals, biotechnology, and telecommunications. Publications and Media Presence Featured in reputable publications such as BBC World, Nature Reviews Drug Discovery, and BioSpectrum Asia, highlighting her contributions to discussions on patents and technology. Prity Khastgir's career reflects a blend of legal acumen, technological insight, and a commitment to empowering others through education and strategic guidance in the rapidly evolving landscape of intellectual property rights.