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.

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.

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.

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.

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.

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.

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.

I’m a logistics and supply chain professional with over 10 years of experience leading operations across the defence, aviation, and FMCG sectors. Currently serving as Key Logistics Manager at Airbus Helicopters in Riyadh, I manage complex, compliance-driven supply chain networks that support critical aerospace and defence programs in the Gulf region. Before Airbus, I spent over five years with Procter & Gamble Pakistan, leading multifunctional logistics and warehouse teams while driving improvements in safety, cost, and service. My specializations include defence logistics, process optimisation, sustainability, and data-driven operations. I hold certifications in CSCP (APICS), PMP, NEBOSH IGC, IOSH Managing Safely, and Data Science Principles from Harvard Online. Recognized with the Great Leader Award from P&G, I’ve also been featured in multiple media outlets for my insights on supply chain transformation and regional connectivity.

I am a healthcare compliance executive and the originator of Stark Watch, a generative AI platform built to monitor physician contracts for strict adherence to the Stark Law and the Anti-Kickback Statute (AKS). As a Compliance Vice President at a $4B health system, I navigate the complexities of healthcare regulations, hospital-physician financial relationships, and corporate ethics on a daily basis. Ensuring physician compensation compliance is one of the most resource-intensive challenges for modern hospitals. Historically, auditing these agreements for Fair Market Value (FMV) and commercial reasonableness required hundreds of hours of manual review. Recognizing this bottleneck, I architected Stark Watch to transform healthcare regulatory technology (RegTech). Our compliance software leverages generative AI to automate contract analysis, detect potential AKS violations, and track compensation tied to Designated Health Services (DHS). By turning a reactive auditing process into a proactive, technology-driven workflow, Stark Watch empowers health systems to protect their bottom line, avoid severe regulatory penalties, and maintain the highest ethical standards in their physician partnerships. With a deep commitment to safeguarding healthcare integrity, I hold triple certifications: Certified in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), and Certified in Healthcare Privacy Compliance (CHPC). My current focus is bridging the gap between stringent regulatory frameworks and cutting-edge technology. I actively use artificial intelligence to streamline compliance operations, ensure alignment with OIG safe harbors, and mitigate AKS and Stark Law risks in complex contracting environments. My professional focus centers on providing actionable insights into the practical application of AI in healthcare administration, the evolving landscape of the Stark Law and Anti-Kickback Statute, and the future of healthcare compliance software. Whether analyzing recent Department of Justice enforcement trends or designing algorithms to parse complex medical directorship agreements, my goal is to make healthcare compliance more efficient, accurate, and accessible.

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.

we specialize in providing end-to-end industrial consulting services, helping businesses navigate complex regulatory landscapes and maximize government incentives. With deep expertise in regulatory approvals, subsidies, and industrial transactions, we ensure seamless project execution for industries of all scales. Our Key Services: ✅ Regulatory Approvals – CTO, CTE, Environmental & Compliance Clearances ✅ Government Subsidies – MSME Subsidy, Mega Subsidy & Customized Incentives ✅ Government Affairs & Policy Consultation – Liaison and Industry-Specific Approvals With a client-centric approach, we simplify compliance, unlock financial benefits, and facilitate smooth industrial expansion. Whether you're setting up a new unit or optimizing existing operations, we provide expert guidance for industrial success. 📩 Let’s connect and discuss how we can add value to your business.

Registered and Licensed Dietitian with over 20 years of specialized expertise in school nutrition and large-scale food service management. A graduate of Illinois State University and St. John’s Hospital Internship, I bridge the gap between clinical nutrition and industrial-scale operations. Currently directing a comprehensive food service department for Quincy Public Schools, overseeing 8 sites (PreK–High School) and a team of 90 professionals to serve a student population of 6,500. Proven track record in fiscal stewardship, USDA regulatory mastery, and the implementation of nutrient-dense, student-centric meal programs that drive participation and community trust.