Sampath Kumar Rompicherla

Sampath Kumar ROMPICHERLA, M.Pharmacy, MRSB, DABT Principal Toxicologist | DABT® |

Global Regulatory & Human Health Risk Assessment Expert

I am a Principal Toxicologist with 14+ years of diversified international experience in global regulatory toxicology, human health risk assessment, and safety compliance across medical devices, pharmaceuticals, OTC drugs, cosmetics, and consumer health. My work spans the complete safety and regulatory lifecycle from early design inputs and formulation assessments to post-market surveillance and complex regulatory engagements. I specialize in translating scientific, in-silico, and toxicological data into clear, defensible, and regulatory-aligned decisions.

My expertise includes FDA, ISO 10993 series, ISO 18562 series, EU MDR, ICH, and OECD frameworks. I routinely perform POD/NOAEL derivation, margin-of-safety calculations, impurity/ingredient safety assessments, and biocompatibility evaluations for global product portfolios.

Core Expertise

• Toxicological Risk Assessment (TRA) for medical devices, combination products, and consumer health
• Biocompatibility SME: ISO 10993-1, -17, -18, -23; ISO 18562 series • Regulatory strategy & dossier development across US, EU, APAC, LATAM
• In-silico toxicology tools, computational modelling, read-across & SAR
• Safety assessments for extractables/leachables, impurities & novel chemistries
• Change management, lifecycle management & global regulatory submissions
• Technical leadership, training, coaching & capability building for cross-functional teams

Over the years, I’ve trained global teams on updated ISO standards, regulatory pathways, and advanced toxicological evaluation methods, including structured programs covering ISO 10993-1/17/18/23, ISO 18562, and complex TRA methodology. I have also led multi-disciplinary biocompatibility and risk assessment teams, driving clarity, compliance, and scientific rigor across programs. I am actively pursuing a part-time PhD in in-silico toxicology, focusing on advancing computational approaches for predictive safety.

I hold the DABT® certification, one of the most rigorous global benchmarks for toxicologists, strengthening the scientific depth and regulatory confidence behind my work.

My professional purpose is simple: to ensure that science, safety, and regulatory excellence meet with speed, clarity, and global impact. I collaborate with teams, innovators, manufacturers, and regulators to solve complex toxicological challenges and support the safe, compliant, and successful launch of products that improve lives.

If you are working on medical devices, combination products, pharmaceuticals, cosmetics, or emerging technologies and need support in toxicology, biocompatibility, regulatory strategy, or in-silico assessments, I'm always happy to connect and contribute.