Leading Pharmaceutical Regulatory 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.

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.

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 am a strategic marketing manager with over 7 years of experience in medical devices and pharmaceuticals, focusing on developing and executing launch strategies and promotional activities. I have a background in brand and product management, with experience in developing value propositions and managing product portfolios. I also have extensive experience managing stakeholder relationships, leading cross-functional teams, and creating data-driven commercial launch plans

Deniz Baynal is the Founder of DetoxCapsuleShop.com, a premium online shop specializing in high-quality herbal detox teas and botanical capsules. With a passion for natural wellness, Deniz curates blends featuring science-supported ingredients like green tea, guarana, goji berry, L-carnitine, and fennel to support gentle detoxification, metabolism, digestion, and energy without harsh effects. Drawing from extensive research into herbal traditions and modern wellness practices, Deniz focuses on safe, effective formulas for daily use. DetoxCapsuleShop products are designed for those seeking clean, plant-based support for bloating relief, natural cleansing, and overall vitality. As an advocate for transparent, non-GMO herbal solutions, Deniz shares insights on proper detox tea usage, ingredient benefits, and combining teas with capsules for optimal results. Available for expert commentary on herbal detox methods, natural supplements, wellness trends, and safe cleansing routines.

- Development of perfume compositions in compliance with IFRA protocols; - Development and adjustment of perfume formulations; - Development of fragrances for candles, soaps, cleaning products, and aroma diffusers; - Three-stage organoleptic production control; - Work with leading companies: BASF, Takasago, Firmenich, IFF, KAE, SOS, Kusado; - Consulting on finished product quality, fragrance adjustments, and the selection of new fragrance compositions; - Chemical synthesis of fragrances at the production facility.

Dr. Akshaya Srikanth Bhagavathula is an Associate Professor of Epidemiology at North Dakota State University, internationally recognized for his pioneering work at the intersection of digital epidemiology, pharmacovigilance, and artificial intelligence. His research harnesses advanced statistical modeling and AI to track and predict health behaviors, medication safety, and disease patterns in real time—bridging traditional epidemiology with next-generation digital health analytics. Dr. Bhagavathula has published more than 250 peer-reviewed articles in leading journals, including Annals of Epidemiology, JAMA Network Open, and Lancet Digital Health. His work has been widely cited and featured in major media outlets such as The New York Times, where he discussed the real-world safety of GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy, Mounjaro). Recognized among the Stanford–Elsevier Top 2% of Scientists (2019–2024) and elected as a Fellow of the American College of Epidemiology, Dr. Bhagavathula is known for translating complex data into actionable insights that shape public health policy and clinical practice. His ongoing projects include NIH- and NSF-aligned initiatives on AI-powered overdose forecasting, digital twins for public health, and real-world drug safety surveillance using explainable machine learning. With a decade of experience spanning more than two dozen countries and collaborations with organizations such as WHO, USAID, and UNICEF, Dr. Bhagavathula brings a global, data-driven, and human-centered approach to solving modern health crises.

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.

Research Credentials: - 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) specializing in public and private international law, with expertise in outer space law, regulatory law, emerging technologies, international trade, and securities law. 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”. In 2025, he was named Top 30 under 30 by the Alberta Council for Global Cooperation. Guided by a commitment to advancing equitable and effective governance of space, Gregory's research aims to drive positive change at the evolving frontier of space law. Gregory is a Fellow of the Centre for Space, Cyberspace & Data Law (CSCDL), an Australian 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, constitutional protections for dark skies, orbital regulation, and the intersection of securities law with technological innovation. Gregory is also an Affiliate at the Royal Aeronautical Society, Executive at Young Diplomats of Canada, and Member of the International Astronautical Federation. Gregory is currently completing a Doctor of Philosophy (PhD) in Law candidate at Bond University, where his research focuses on dispute resolution and regulatory frameworks for conflicts among public and private space actors.

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.

Gerrid Smith has been quoted on INC.com, Forbes.com, Entrepreneur.com and CIO.com. His former company, Black Fin, was featured on the 2017 INC 5000 list at #821 and specializes in high-end digital marketing strategies. His personal specialties are in: - Google Analytics Analysis - Conversion Rate Optimization - Lead Tracking & Nurturing - Technical SEO Audits - Modern + Responsive Web Design - Legally Compliant Social Media Campaigns - PR Outreach for Link Acquisition - Video/YouTube Promotion - Inbound Marketing & Strategy - Sponsorship Opportunity Analysis - Funnel Strategy and Implementation - Content Marketing

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.

Full-stack Product Engineer with 6+ years of building and shipping web, mobile, and desktop apps using AI. Proficient in JavaScript/Typescript and Cloud frameworks. 4x hackathon winner, achieved 5M+ in social media views, and built 2 SaaS with $5k+ revenue each. Worked in healthcare, blockchain, developer tools and content industries.

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.

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.

I am a third-generation pharmacist with certifications in pharmacogenetics and antepartum doula care, specializing in maternal health and medication safety. After earning my PharmD from Creighton University and a BS in Hospitality from UNLV, I built a career spanning hospital and retail pharmacy, consulting, entrepreneurship, telemedicine, and medical affairs. Currently, I work as a medical science liaison while continuing to consult and practice as a hospital pharmacist. My expertise is grounded in both research and lived experience. After enduring three pregnancies complicated by Hyperemesis Gravidarum (HG), I founded HG Pharmacist® and Obstet-Rx to provide personalized medication guidance, integrate pharmacogenetics into maternal care, and advocate for women worldwide. My research includes genetic predictors of ondansetron effectiveness and recurrence risk for HG, and I have published extensively on maternal health. I also served on the HER Foundation board from 2019 to 2021 and frequently present at professional conferences. As host of the MaternalRx podcast on the Pharmacy Podcast Network, I highlight the pharmacist’s role in maternal outcomes, drawing from my background in specialty diagnostics such as preeclampsia biomarkers, iron deficiency anemia, and oncology supportive therapies. This blend of patient advocacy, clinical expertise, and medical affairs experience positions me as a trusted voice on maternal health, medication management, and the evolving role of pharmacists in healthcare. When I’m not speaking or consulting, I enjoy yoga, ice skating, and time outdoors with my dog. I welcome opportunities to collaborate with media to shed light on maternal health challenges, the importance of personalized medicine, and strategies to improve patient outcomes.