Recognized Medical Device Regulatory Experts Leaders 2025

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.

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.

Andreas Rind is the managing director of arinda and specializes in Creo Parametric in mechanical engineering. Since 1999, he has successfully trained approximately 6,500 participants from over 170 companies in Germany, Austria, and Switzerland. He is the author of the book “Leitfaden für Skizzen” (Guide to Sketching), which will be published in its 4th edition with additions in December 2025. His focus: putting people at the center. Robust model design, stable and change-friendly sketches, parts and assemblies, and efficient variant models are the result of his methodology, which he uses to guide users toward independence. In his QuickCheck, he analyzes the working methods of entire design departments. He then helps people with CAD guidelines, individual consulting, and training, and translates best practices into tangible steps for design teams—with measurable effects on stability, change effort, and time-to-release. Typical topics: Structure & references, family tables, drawing derivation, sheet metal design. Goal: Less rework, secure reuse, faster releases. Translated with DeepL.com (free version)

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.

Zaeem Chaudhary, MCIAT, is the Director of AC Design Solution, a multidisciplinary architectural and engineering practice in London. He has delivered over 10,000 residential projects the UK. His expertise covers architecture, structural engineering, building regulations, and party wall services. Zaeem specialises in making complex alterations stress-free for homeowners and developers, with a focus on extensions, loft conversions, and structural modifications.

As a strategic advisor, alliance builder, and subject matter expert with over two decades of experience, I help global enterprises and public sector organisations navigate the complexities of data management, eDiscovery, and cyber risk in an era of accelerating digital regulation and unstructured data growth. My background spans leadership roles in enterprise technology sales, consulting, and service delivery, focusing on data-intensive environments where compliance, litigation readiness, and operational intelligence are critical. With hands-on experience in incident response, breach investigation, and regulatory frameworks like GDPR and NIS2, I’ve helped organisations transform reactive data chaos into strategic business insight. Through my consultancy work, I lead programmes that address the core challenges enterprises face today: outdated storage architectures, fragmented data strategies, and the proliferation of ROT (redundant, obsolete, and trivial data) and “dark data” information collected but never utilised. I enable clients to regain visibility, reduce risk, and comply with strict data retention requirements such as GDPR’s 7-year rule, DSARs and Right to be Forgotten. My expertise is underpinned by next-gen tools like Lightning IQ capable of indexing up to 1.3 billion files per hour enabling scalable, low-impact analysis of petabyte-scale unstructured data environments. This supports advanced use cases, from compliance and litigation readiness to AI enrichment, ESG reporting, and cloud transformation. Whether advising C-level stakeholders, partnering with global system integrators, or leading high-impact data optimisation projects, my goal is always the same: to convert complexity into clarity, and risk into opportunity.

I am an award winning highly quantitative Product Development Engineer who specializes in transforming raw silicon characterization data into predictable, high-yield products ready for mass production, with direct experience on cutting-edge 3nm and 2nm processes crucial for next-generation AI and ML hardware. My expertise is rooted in applying Statistical Design of Experiments (DOE) and advanced methodologies like Six Sigma directly to post-silicon issues. I leverage deep data analysis to quickly pinpoint and eliminate root causes of complex parametric and functional failures within System-on-Chip (SoC) architectures. Notably, I personally conceptualized and implemented the entire Yield Management System for ARM, a multi-billion dollar entity, delivering a mission-critical infrastructure solution at virtually zero dollar cost. This rigorous, data-driven approach is key to achieving robust product quality and accelerating the time-to-market for every new silicon generation. I was also as named a Thinkers360 Top 25 Global Thought Leader and Influencer in the "Engineering" category and a Top 50 Global Thought Leader and Influencer in the "Future of Work" category for 2025.

Dr. Danilyants completed her fellowship in Minimally Invasive Surgery (MIS) with an emphasis on GYN Oncology techniques and procedures through the prestigious Johnson and Johnson/Ethicon MIS fellowship training program. She brings over two decades of experience in minimally invasive GYN surgery treating complex conditions including endometriosis, adenomyosis, and fibroids, and has developed advanced protocols for the performance of hysterectomy and myomectomy in the free-standing ASC setting. She is the developer of two advanced MIS procedures: DualPortGYN® and Laparoscopic Assisted Abdominal Myomectomy® (LAAM®), which are widely recognized for improving surgical outcomes in patients with endometriosis, fibroids, and pelvic masses. Dr. Danilyants has published some of the largest comparison data on Dualport for hysterectomy and endometriosis and LAAM in hospital, hospital outpatient department (HOPD), and ASC settings. She has performed thousands of these procedures and actively trains other surgeons in these techniques. Dr. Danilyants is a national and international leader on Value Based Care, with a focus on the role of the free-standing ASC to decrease healthcare costs while increasing value and optimizing surgical outcomes. Dr. Danilyants has held leadership positions across multiple institutions. She was the Director of Advanced Laparoscopic Retroperitoneal Surgery at the Women’s Surgery Center (Bethesda, MD), Director of Minimally Invasive Surgery at INOVA Fair Oaks Hospital (Fairfax, VA), as well as Assistant Professor of Obstetrics and Gynecology at the George Washington University Medical Center (Washington, DC).

Masters in Biomedical engineering with experience in bioanalytical chemistry and quality control of research peptide synthesis .

Cynthia Udoka Duru has led innovative projects across various sectors, from driving cloud-native system design, automated CI/CD workflows, and infrastructure lifecycle management to architecting solutions, contributing to digital health, finance & maritime cybersecurity, enabling exponential growth, improving infrastructure efficiency, and supporting award-winning innovation across Africa and Europe.

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.

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.

Supriya Bachal is an AI Engineer and researcher focused on trustworthy AI, LLM evaluation, and production-grade ML systems. Her work spans generative AI, safety-critical automotive systems, and scalable cloud pipelines. She publishes research, builds open-source tools, and mentors emerging technologists. Passionate about ethical AI and social impact, she enjoys transforming complex ideas into practical systems.

I am the Chief Medical Officer at Boomerang Health Care, a state of the art multidisciplinary specialty group offering interventional, surgical and rehabilitative care through its 25 clinics in California. I also serve as the Medical Director at Le Reve: Regen, a leader in cutting edge restorative and regenerative solutions for Spine, Orthopedics and Musculoskeletal conditions. In the academic world, I have served as a Clinical Faculty at Stanford University for more than 20 years and have established myself as a world leader in cutting edge innovative therapeutic solutions. I completed her Anesthesiology residency from Medical College of Wisconsin, Milwaukee and Fellowship in Pain Medicine from the University of California, Davis. I am board certified in Anesthesiology and Pain Medicine by American Board of Anesthesiology, in Interventional Pain by American Board of Interventional Pain Physicians and in Regenerative Medicine by American Board of Regenerative Medicine. I sit on the Editorial board of the journal, Pain Physician and serve on the board of the American Society of Interventional Pain Physicians, Latin American Pain Society, California Society of Industrial Medicine and Surgery, California Society of Interventional Pain Physicians and Scilex (Nasdaq: SCLX). I am humbled to receive the Distinguished Service Award, Outstanding Achievement Awards and other accolades. I have devoted my entire career to the field of Interventional spine and Regenerative medicine and have contributed via several peer reviewed journal articles, visionary editorials, and book chapters. My book, “Essentials of Regenerative Medicine” is first in its right illustrating latest interventional biologic techniques for spine and musculoskeletal injuries. I have also authored several National Guidelines including the ones on Opioids, Interventional Spine Epidural procedures, Facet joints, and the first ever on the Safe and Effective use of Biologics in Lumbar spine. I have completed the first prospective, multicenter, randomized placebo controlled trial demonstrating efficacy of platelet rich plasma and bone marrow concentrate in patients with back pain related to disc injury/degeneration. I consider myself an authority on global health care trends including digital health, technology innovations and applied biologics. Let’s connect and work together to make healthcare better, faster, and more effective – www.annunavani.com.

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.

Experienced Delivery Manager with a proven track record in managing and delivering custom software development projects. Skilled in coordinating cross-functional teams, optimizing workflows, and ensuring project milestones are met within budget and timelines.With over 15 years of experience, I have successfully led projects in diverse industries, focusing on creating tailored solutions that meet client needs and drive business value. My expertise includes stakeholder communication, resource planning, and risk management, all backed by a strong technical foundation.I thrive in dynamic environments, where I can apply my leadership skills to foster collaboration, enhance team performance, and deliver exceptional results. Currently exploring opportunities to contribute my skills to impactful projects in technology-driven sectors.