Most Recommended Regulatory Affairs 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:

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.

Result-oriented regulatory specialist with invaluable experience in the GMP (Good manufacturing process) -certified pharmaceutical and medical device industries. Adept at quickly gathering, analyzing, and submitting data in order to ensure effective regulatory compliance. An energetic, self-driven team player with strong organizational skills, poised to secure a full-time position as a Regulatory Professional within a cutting-edge company. I am dedicated to utilizing my skills and contribute my knowledge to drive continuous growth while further enhancing my professional acumen.

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.

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 💬

For approximately the last 30 years, I have worked within and with organizations to help them to address the challenges presented by climate change and sustainability. Frustrated by the unnecessary complexity in these areas, my mission is to simplify the complex for the greater environmental benefit and provide cost effective solutions to help organisations on their sustainability journey. My understanding of regulations, their direction and evolution has enabled me to simplify this complexity and influence company strategies to ensure the risks presented are managed and the potential of new opportunities realized. My knowledge across a broad spectrum of sustainability regulations and carbon markets of the UNFCCC, EU ETS, and domestic schemes in the UK, US, Kazakhstan, Korea, China and and sector specific schemes such as EU MRV, UK MRV and IMO DCS, enables me to advise both global and local players, on all sustainability issues wherever they are. I relish opportunities to design regulations, guidance, standards, schemes, and management systems and in understanding and implementing approaches and tools for them for business benefit. I have helped governments and organisations work through the maze of technical, operational and commercial issues that must be navigated to realise the opportunities of new regulatory requirements in these areas. I am privileged to have written for leading publications and speak on climate change and sustainability subjects at a variety of events. I have also designed and delivered tailored workshops and training courses on numerous subjects including: Extended Producer Responsibility, Recyclability Assessments, Environmental Auditing, Environmental and Energy Management Systems, Carbon Footprinting, Net Zero approaches, Verification, CSR, EU ETS, MRV and Electricity Capacity Markets for specific organizations, governments and business groups. I pride myself on my ability to simplify the complex and provide understanding where there may be confusion.

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

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.

Senior Compliance Specialist dedicated to bridging the gap between complex regulation and practical engineering. Over a decade of hands-on experience in EMC, Product Safety and Global Market Access. Currently focusing on Cybersecurity.

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.

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

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

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

Tara Bailey, MPA, CMC, BCPA, CDP, CSA®, SHSS Founder & CEO | Brevard Healthcare Navigation Tara Bailey is a nationally credentialed care manager and patient advocate with nearly two decades of experience in healthcare support services. She holds a Master’s in Public Administration (MPA) and is certified as a Care Manager (CMC), Board Certified Patient Advocate (BCPA), Certified Dementia Practitioner (CDP), Certified Senior Advisor (CSA®), and Certified Senior Home Safety Specialist (SHSS). As the Founder and CEO of Brevard Healthcare Navigation, Tara leads a trusted team dedicated to helping seniors, disabled adults, veterans, and families navigate complex medical systems with clarity and confidence. Her work is rooted in personal experience, deep empathy, and a belief that every individual deserves coordinated, dignified support—whether facing a health crisis or planning ahead. In addition to her direct work with clients, Tara has served on multiple local, state, and national board of directors, advocating for improved care access and quality across the lifespan. She is known for her calm presence, strong leadership, and unwavering commitment to empowering others through advocacy, education, and compassionate guidance.

Natalia Taft is a seasoned compliance executive and independent regulatory advisor with over 20 years of experience working with regulated financial institutions across the United States, Europe, and international markets. She has held senior compliance leadership roles at global banks, broker-dealers, the world’s largest asset management firm, and fintech companies, as well as advisory roles at Big Four consulting firms. Natalia specializes in designing and implementing flagship global compliance programs. Her expertise includes managing complex regulatory remediation and transformation programs — particularly following supervisory findings, licensing events, or organizational changes — as well as overseeing AI- and data-driven compliance governance. Throughout her career, Natalia has successfully guided companies through complex regulatory challenges and enforcement actions imposed by the U.S. Federal Reserve, SEC, FINRA, NYSDFS, and various European regulators. Her expertise also includes leading compliance program transformations, independent audits and reviews, and regulatory investigations.

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.

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

Rohan Desai – BI Analyst | Data Analytics | Healthcare Technology Results-driven Data Analyst / BI Developer specializing in healthcare analytics, data visualization, and revenue cycle management (RCM). Proven expertise in data regression modeling, business intelligence (BI) solutions, and process automation to enhance operational efficiency and decision-making. Passionate about leveraging data-driven insights to solve complex business challenges. Expertise: Business Intelligence (BI) | Data Modeling | SQL | Power BI | Tableau Healthcare Revenue Cycle Management (RCM) | Financial Analytics Cloud Computing (Azure) | Big Data Processing Publications: Published 7+ research papers on Healthcare Technology & Analytics Medium Page: https://rohan-desai.medium.com/

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.