Leading Pharmaceutical Regulatory Experts

Imtiaz Ibne Alam, B.Pharm, RPh, is a registered pharmacist and freelance medical writer with 15+ years of experience across healthcare, pharmaceutical writing and scientific communication. He writes and edits peer-reviewed manuscripts, systematic reviews, pharmacovigilance and drug safety documents, regulatory and CMC content and patient education on topics such as diabetes and glucose monitoring. He has supported 20+ indexed publications and is a named co-author in the Journal of Integrative Medicine. He is available to comment on medical writing, publication ethics, drug safety, evidence-based health content and the responsible use of AI in medical writing.

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 💬

Vardan Ter-Antonyan is a pharmaceutical research and development executive with more than 20 years of experience advancing products from concept through commercialization. His expertise spans drug formulation, pharmaceutical development, manufacturing scale-up, quality systems, regulatory strategy, and commercialization across pharmaceuticals, medical devices, nutraceuticals, cannabinoids, and medical technologies. Throughout his career, Vardan has led multidisciplinary R&D teams, developed novel drug delivery systems, optimized manufacturing processes, and helped organizations bring innovative products to market while navigating complex regulatory requirements. His technical expertise includes lipid-based drug delivery systems, nanoemulsions, self-emulsifying drug delivery systems (SEDDS/SNEDDS), liposomes, controlled-release technologies, and formulation development for poorly water-soluble compounds. In addition to his scientific leadership, Vardan is passionate about bridging the gap between research and commercial success. He regularly advises companies on product development strategy, technology commercialization, operational excellence, and innovation management. His work combines deep scientific knowledge with practical business insight, enabling organizations to accelerate development timelines, improve product quality, and reduce technical risk. Vardan is also an author, speaker, and industry thought leader who enjoys sharing evidence-based perspectives on pharmaceutical innovation, drug delivery, biotechnology, diagnostics, manufacturing, and executive leadership. He welcomes opportunities to provide expert commentary for journalists covering advances in pharmaceutical science, healthcare innovation, biotechnology, regulatory affairs, and emerging medical technologies.

I'm a pharmacist and healthcare professional with more than 20 years of experience across pharmaceutical inspection, healthcare quality management, occupational health and safety, and clinical pharmacy. I earned my Bachelor of Pharmacy in 2005 and began my career in pharmaceutical inspection, working with pharmaceutical regulations, quality standards, and medication compliance. This experience gave me a strong understanding of healthcare quality and safety and shaped my commitment to improving patient and public health outcomes. I later moved into healthcare quality management, where I worked on quality improvement, patient safety, accreditation, and risk management. Today, I work in Occupational Health and Safety Management, helping organizations create safer workplaces while promoting employee health and wellbeing. I'm also in the final year of a Professional Master's degree in Clinical Pharmacy, continuing to develop my knowledge of pharmacotherapy, evidence-based medicine, and clinical decision-making. Over the years, I've developed a particular interest in making complex healthcare information easier to understand and apply in everyday life. I believe good health communication should be accurate, practical, evidence-informed, and free from unnecessary medical jargon. I'm also the founder of LULIQUA, a UK-registered wellness company focused on evidence-informed approaches to pain relief, recovery, and everyday self-care. This work has strengthened my interest in consumer wellness, product evaluation, and responsible health communication. My areas of expertise include pain management, heat therapy, musculoskeletal health, workplace wellness, occupational health and safety, healthcare quality, patient safety, medication safety, preventive healthcare, clinical pharmacy, and evidence-based wellness. I'm happy to provide clear, evidence-informed commentary for journalists, editors, and content creators covering healthcare, wellness, workplace health, and related topics. For expert commentary or media enquiries: 📧 ghada@luliqua.com

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 am an expert in Generative AI and Robotic Process Automation (RPA). I have built solutions from scratch and successfully executed these technologies for various use cases, including market research. By combining AI and RPA, I have increased productivity in secondary research, creative content creation at scale, and infographic image generation at scale, leading to a multifold improvement in efficiency. I also founded MarketRytrAI, a platform that leverages Generative AI and Natural Language Generation (NLG) to create customized, data-driven market research reports for a wide range of industries and segments. I am passionate about the potential of AI and RPA to create impactful solutions. If you're interested in learning more, feel free to reach out at sormare.bcp@gmail.com.

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’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'm a Pharm.B student with a background in pharmacology and biochemistry, and the founder of NakedCompound.in — a research-backed supplement review platform built for Indian buyers. I specialize in analyzing clinical evidence behind supplement ingredients, evaluating label accuracy, identifying underdosed or adulterated products, and translating complex pharmacology into practical guidance for everyday consumers. My work covers protein supplements, creatine, ashwagandha, BCAAs, pre-workouts, and other sports nutrition compounds — with specific context around FSSAI regulations, Indian brand quality standards, and bioavailability in Indian dietary patterns. I'm available to comment on supplement science, sports nutrition, nutraceutical safety, ingredient interactions, and the Indian wellness market.

Shane Hellmrich holds a BSc in Health Promotion and has spent the past 11 years independently testing and reviewing online modafinil vendors — placing personal test orders, verifying product authenticity, and documenting shipping reliability across dozens of suppliers. His work at BuyModa.net tracks over 1,300 verified customer transactions and maintains a public testing methodology that has become a trusted reference point for consumers navigating the grey-market pharmaceutical space. Shane's research covers vendor reliability scoring, product authentication, shipping logistics across international jurisdictions, and the pharmacokinetic profiles of generic modafinil products. He is regularly consulted on topics including nootropics and cognitive enhancement, online pharmacy safety and regulation, pharmaceutical sourcing and supply chain transparency, consumer protection in unregulated markets, and the real-world usage patterns of prescription cognitive enhancers. Shane is available for expert commentary, background briefings, and on-the-record quotes for journalists covering health, productivity, pharmacology, biohacking, and consumer safety.

I am a PhD-level regulatory and clinical research consultant and Founder of Klynical Consulting & Services, with over 15 years of experience supporting academia, investigators, startups, and established companies across the pharmaceutical, biotechnology, medical device, aesthetic, and dermo-cosmetic sectors. My work spans the full research and development lifecycle, from early concept and feasibility through regulatory submission, clinical execution, and results dissemination. I provide strategic regulatory and clinical research consulting across Health Canada, the U.S. FDA, and the European Medicines Agency (EMA), with experience supporting early-stage and pivotal programs, including first-in-human studies, investigator-initiated research, and post-market evidence generation. My regulatory expertise includes study design alignment with jurisdiction-specific expectations, preparation and review of regulatory submissions, and early engagement strategies to de-risk development pathways. My therapeutic expertise includes dermatology, aesthetic medicine, plastic surgery, anatomy, and dermatologic oncology, as well as adjacent areas such as medical devices, digital health (AI), and health innovation. I regularly work on interventional and non-interventional studies, real-world evidence programs, and product validation initiatives, ensuring that scientific rigor, operational feasibility, and regulatory compliance are addressed in parallel. In addition to consulting, I am actively involved in research mentorship and academic collaboration, working with graduate students, medical students, residents, and early-career investigators. I provide guidance on research question development, study methodology, academic writing, journal strategy, and conference submissions, and I frequently collaborate on manuscripts leading to peer-reviewed publication and co-authorship.

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.

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.

I edit Europe Pharma Today — a Europe-first news desk covering EMA and CHMP decisions, EU HTA, and national market-access moves for industry professionals. We focus on what changed, what it means for access, and what to watch next — with clear sourcing, not noise.

I have a degree in pharmacy, with a specialization in cosmetics and have been working in the industry for the past decade. Firstly, as a training manager for YOUTHLAB. Portugal, and then as a content writer for Care to Beauty. Throughout the years, I've become the head of the department that handles everything related to cosmetic products, including PDP details, blog articles and product recommendations. We handle several areas that touch pharmaceutical cosmetic advice, SEO (technical and on-page), customer experience design, content creation, and e-commerce strategy.

I am an entrepreneur and business leader with extensive experience building, scaling, and exiting nationally recognized dietary supplement and weight management brands. My background spans supplement manufacturing, product development, formulation strategy, operations, supply chain, direct-to-consumer marketing, and brand growth within the wellness industry. I have founded and grown multiple consumer health brands from concept through commercialization and acquisition, including Pounds Off, Lipozene, Inmit Fasting, and Fiber Thin. Throughout my career, I have led product innovation, manufacturing partnerships, regulatory compliance, quality assurance, customer acquisition, e-commerce growth, retail expansion, and large-scale direct response marketing campaigns. My expertise lies in turning product ideas into scalable businesses by aligning formulation, manufacturing, marketing, operations, and financial strategy. I have built high-performing teams, negotiated strategic partnerships, launched new product lines, optimized retention strategies, and led successful merger, acquisition, and exit transactions. I bring a practical, growth-focused perspective to supplement brand development, helping companies identify opportunities, improve operational efficiency, strengthen product-market fit, and increase long-term enterprise value.

Registered Superintendent Pharmacist with extensive experience in clinical pharmacy, medicine procurement, and patient care standards within the UK healthcare sector. Specializing in pharmaceutical compliance, cross-border prescription fulfillment, and managing digital pharmacy operations. Dedicated to ensuring patient safety, medication authenticity, and strict adherence to regulatory standards.

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.

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