Most Recommended Regulatory Affairs 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 💬

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.

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.

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'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.

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.

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:

Dr. Philip D. Mann is an aviation safety and AI governance specialist who spent seventeen years inside the Federal Aviation Administration before founding Vector Strategic Consulting LLC. He rose from field technician to business analyst to instructor and training program manager at the FAA Academy, the agency's training center for the workforce that keeps the National Airspace System running. That path lets him speak about outages, controller staffing, and stalled modernization programs from inside the operation rather than from a press release. His commentary centers on three areas: aviation safety and National Airspace System infrastructure; the governance of artificial intelligence in critical systems where failure carries physical consequences; and the organizational risk, leadership, and human factors that decide whether a safety program holds under pressure. A single argument runs through the work: institutions tend to govern by disaster, writing rules only after the wreckage forces the issue, when they could govern by design and move accountability upstream of the failure. He is the author of The SCAR Framework: A Systematic Approach to AI Decision-Making in Critical Systems, a structured method for deciding when to trust automated systems where a wrong call can cost lives, built on four dimensions: Safety, Complexity, Accountability, and Resilience. His analysis has reached more than 35 million people worldwide across outlets including the Associated Press, USA Today, New Scientist, NewsNation, LiveNOW from Fox, LBC Radio in London, and Deutsche Welle. He works comfortably in print, on camera, and on live radio, holding a technical point in plain language for a general audience or speaking at full depth with a trade or policy reporter. Dr. Mann holds a PhD in Organization and Management, an MBA, an MPA, and a BS in Business Management, with PMP and PMI-RMP certifications. He responds quickly to deadlines and supports every claim with primary sources: FAA orders, NTSB findings, court records, and agency rulemakings.

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.

Regulatory compliance consultant and trainer based in Cyprus, specialising in EU financial services regulation. CFA charterholder with CySEC Advanced and AML certifications. Founder of CPDs.Academy, a CySEC-accredited online training platform for compliance professionals. Former Head of Compliance at XM (Trading Point) and founder of Hesper Capital, a CySEC-authorised AIFM. Available to comment on MiFID II, MiCA, AML/CFT and the EU AML Package, DORA, market abuse and insider dealing, CySEC enforcement, suitability and product governance, and the EU Retail Investment Strategy. Recent regulatory analysis has covered MiCA implementation across the EU, MAR insider dealing enforcement, MOKAS findings on financial crime in Cyprus, and ESMA's 2025 supervisory action on marketing communications. Educated at Bayes Business School, City, University of London. Writes regularly for CPDUK and publishes regulatory analysis at CPDs.Academy.

Dr. Anil Gupta is the Chairman of Connect Ventures Group of Companies (including www.complyglobally.com), a corporate collective dedicated to transforming Indian startups and MSMEs into international multinational corporations. As a leading authority on cross-border compliance, global mobility, and international taxation, I've spent decades guiding enterprises through the regulatory frameworks of more than 45 nations. My strategic philosophy uniquely bridges cutting-edge modern business mechanisms such as AI-driven operational scaling with timeless civilizational narratives, advocating for a model of global expansion built on collaboration rather than conquest. Through Comply Globally an initiative of Connect Ventures, I am actively building the critical infrastructure required to turn India's domestic innovators into globally respected corporate conglomerates.

I have 24 years of experience in the credit counseling industry, specializing in operations, compliance, debt management, and consumer financial education. As Senior Manager of Compliance and Media at Money Fit, I ensure our programs meet strict standards for integrity, accuracy, and regulatory compliance. I am a HUD Certified Housing Counselor and serve on the Board of Directors for the Financial Counseling Association of America (FCAA). My work focuses entirely on nonprofit credit counseling. I help consumers understand the clear mechanics of regulated debt management versus the risks tied to for-profit debt settlement. Consumers deserve straightforward financial guidance that is realistic, responsible, and built for actual progress.

Lorena Tambini is an Accountability & Enforcement Analyst focused on public trust, oversight failure, and institutional accountability. She helps journalists, civic organizations, watchdogs, and public-interest communicators understand where accountability actually failed by identifying who held authority, what action was required, what happened instead, and why the gap matters. Her work focuses on government accountability, enforcement gaps, administrative breakdowns, institutional legitimacy, misinformation resilience, and public narrative risk. Through Take Back Democracy, Lorena translates complex legal and political developments into plain-English public education without spin, panic, or manipulation. She is available for commentary on public trust, oversight failures, accountability gaps, agency dysfunction, election information integrity, AI and public trust, misinformation, and democratic resilience.

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.

I have a passion in Maltese economic and legal ecosystem, with over a decade of experience navigating citizenship, residency, and tax legislation. As the founder of FreeMalta.com and MaltaInsider.com, I’ve pioneered the "Infrastructure of Truth" concept - replacing outdated governmental and institutional data with high-velocity, real-time benchmarks. My expertise covers Maltese Citizenship by Merit, MPRP residency frameworks, and cross-sector salary, cost of living benchmarking. I recently overhauled outdated Maltese legislative data on global platforms (including Wikipedia) to ensure transparency for international investors and expats. I provide data-backed insights for journalists looking for the ground truth on Malta’s evolving regulatory landscape.

Dr. Saravanan Thangarajan is a global climate, health, and equity governance advisor focused on how heat, air pollution, and resource insecurity shape health outcomes in climate vulnerable settings. His work connects policy, financing, and frontline service delivery, with a strong emphasis on maternal health, mental health, and community resilience. Trained in dentistry, health administration, and global health delivery, he brings operational and systems experience across public health programs and digital health infrastructure. He provides clear, quote ready insights on climate adaptation for health systems, equity centered governance, and implementation pathways that move evidence into action.

Legal researcher and advisor with 18 years of experience in U.S. and Canadian immigration law, administrative and public law, and corporate and commercial matters. LLM, George Mason University — Antonin Scalia Law School. Published peer-reviewed researcher in international law journals covering access to justice, immigration frameworks, and cross-border legal systems. Based in Raleigh, North Carolina.

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) and lecturer specializing in outer space law, regulatory law, and emerging technologies. 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”. Gregory is a Senior Teaching Fellow at Bond University and a Fellow of the Australian Centre for Space, Cyberspace & Data Law (CSCDL), an 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, megaconstellations, constitutional protections for dark skies, orbital regulation, and the intersection of securities law with technological innovation.

Ashish Garg is a Principal Product Manager with 15+ years scaling AI/ML products and product operations at Fortune 100 firms. He works at the intersection of Product Ops, enterprise planning, and applied AI, focused on the "front door" of delivery: intake, triage, prioritization, and the rituals that turn strategy into shipped outcomes. In his enterprise planning work, he architected a centralized planning platform that institutionalized Continuous Planning and reduced PM coordination time by 40%. He also leads GenAI initiatives for product teams, including custom assistants and agentic workflows built on RAG and multi-contextual prompting architectures. His earlier work in Financial Planning and Supply Chain Finance delivered measurable operational impact through ML products spanning productivity, forecasting, and churn prediction. Ashish believes the failure mode in complex organizations isn't effort but unclear ownership, hidden dependencies, and decisions that can't be defended later. He designs AI-assisted workflows where humans stay in control, outputs are grounded in evidence, and decision trails are explainable to leadership. He's a recognized thought leader on enterprise AI productization, frequently speaking at industry conferences on his frameworks for scalable, trustworthy AI delivery.