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.

I'm a Pharm.B student with a background in pharmacology and biochemistry, and the founder of NakedCompound.in — a research-backed supplement review platform built for Indian buyers. I specialize in analyzing clinical evidence behind supplement ingredients, evaluating label accuracy, identifying underdosed or adulterated products, and translating complex pharmacology into practical guidance for everyday consumers. My work covers protein supplements, creatine, ashwagandha, BCAAs, pre-workouts, and other sports nutrition compounds — with specific context around FSSAI regulations, Indian brand quality standards, and bioavailability in Indian dietary patterns. I'm available to comment on supplement science, sports nutrition, nutraceutical safety, ingredient interactions, and the Indian wellness market.

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.

https://pharmacisttested.com/

I am the co-founder of Pure Global, a medical device regulatory consulting firm helping MedTech manufacturers secure international regulatory approvals and expand into new markets. With more than 20 years of experience in software engineering and over 15 years in finance, I bring a multidisciplinary perspective to the medical device industry, combining technical expertise, regulatory strategy, data intelligence, and commercial insight. At Pure Global, I help manufacturers navigate complex regulatory pathways across the United States, European Union, Middle East, Canada, Latin America, Asia, and Australia. My work focuses on using AI-native, data-driven regulatory intelligence to identify practical compliance pathways, monitor global regulatory changes, and accelerate market access while maintaining rigorous safety and compliance standards. Before co-founding Pure Global, I owned a boutique big data and cybersecurity firm serving Fortune 500 clients and gained experience with multinational consulting firms including Deloitte and PwC. My background in software, finance, cybersecurity, and market research gives me a unique ability to translate complex regulatory and technical challenges into actionable business strategies for MedTech companies. I hold a Master of Science in Information Security and Technology Management from Carnegie Mellon University and a Bachelor of Science dual degree in Information Science & Technology and Finance from Penn State University.

Shikhar Bhatt is Head of Operations at Euro Biom Ltd, a UK MHRA-licensed pharmaceutical wholesale exporter (WDA(H) 59239) operating from Heathrow into hospitals, ministries and NGOs across GCC, Africa, Europe and Asia. He works on the day-to-day mechanics of named patient supply, drug shortages, cold-chain logistics for 2-8 degC biologics, and the regulatory documentation pack that moves between MHRA, SFDA (Saudi), MOHAP (UAE), MOPH (Qatar), KDFCA (Kuwait), NAFDAC (Nigeria), PPB (Kenya), EDA (Egypt) and SAHPRA (South Africa). Holds an LLM in Commercial and Corporate Law from Queen Mary University of London (2025). Available to comment on UK pharmaceutical export, post-Brexit medicine supply, named patient and unlicensed medicines pathways, GCC and African hospital pharma procurement, cold-chain logistics to high-ambient destinations, and the documentation realities behind cross-border named patient supply.

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.

I'm Eric Franco-Velez, an operations and manufacturing quality professional with 25+ years of hands-on experience in heavy industrial environments — including coatings, fabrication, metal processing, and industrial manufacturing operations. Credentials: AMPP Senior Coatings Specialist | ISO 9001 Certified Internal Auditor | Six Sigma Green Belt | Operations Manager Areas of expertise: ISO 9001 quality management systems — implementation, internal auditing, certification preparation, and clause-level requirements ISO 14001 environmental management — including the April 2026 revision (ISO 14001:2026) and transition requirements ISO 45001 occupational health and safety management — alignment with OSHA 29 CFR requirements in manufacturing IATF 16949 automotive quality management ISO 13485 medical device quality management systems and FDA QMSR transition OSHA compliance for manufacturing and industrial operations ANSI and industry-specific standards for fabrication, welding, and heavy industrial work Environmental compliance — VOC emissions, hazardous waste management, spill containment, wastewater, stormwater Special process documentation — welding, coating, heat treat Supplier quality management and Tier 1/Tier 2 supply chain compliance ISO certification cost, timeline, and audit preparation About The Standards Navigator: I'm the founder of The Standards Navigator (thestandardsnavigator.com) — an ISO and industrial compliance resource site serving quality managers, EHS coordinators, operations directors, and compliance professionals across manufacturing and medical device industries. The site publishes practitioner-focused guides on ISO 9001, ISO 14001, ISO 45001, ISO 13485, IATF 16949, and related standards — written from the perspective of someone who has managed these systems in real manufacturing environments, not from a consulting or academic background. I'm available for expert commentary, source quotes, and contributed content on ISO standards, manufacturing compliance, environmental management, occupational safety, and industrial quality systems.

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.

Ziad Meras is an organic chemist (M.Sc.) with peer-reviewed publications in photochemistry (Google Scholar: https://scholar.google.com/citations?user=W5HQX0oAAAAJ&hl=fr). He specializes in longevity supplement biochemistry — particularly NAD+ precursors (NMN, NR), mTOR/AMPK pathway modulators (berberine, resveratrol), and senolytic mechanisms. At Thrive Trilogy, he evaluates supplement formulations using third-party Certificate of Analysis data and clinical trial evidence, bridging the gap between molecular biology research and consumer supplement products. His expertise includes supplement bioavailability chemistry, purity verification methods, and the translation of preclinical longevity research into practical supplementation protocols.