Medical Toxicology Consulting

Service Description

Ensuring Drug Safety Throughout Development From early-stage research to post-market surveillance, we assist in identifying and mitigating safety risks that can impact drug approval and patient outcomes. Our expertise covers: Drug-Induced Liver Injury (DILI): Assessing hepatotoxicity risks, biomarkers, and regulatory expectations. Renal Toxicity & Drug Safety: Evaluating nephrotoxic risks and early detection strategies. Cardiovascular Safety: Investigating QT prolongation, arrhythmias, and hemodynamic effects of therapeutics. Neurologic & CNS Risks: Addressing seizure risk, neurotoxicity, and cognitive effects of new drugs. Regulatory & Preclinical Toxicology: Guiding IND, NDA, and BLA submissions with a focus on safety data. Bridging Science, Medicine, and Regulation With extensive clinical and industry experience, we provide scientifically rigorous, actionable insights to support: Risk-Benefit Assessments & Safety Strategy Development Regulatory Submissions & FDA/EMA Safety Reviews Pharmacovigilance & Post-Marketing Surveillance Due Diligence for Investors & Biotech Startups By combining toxicology, clinical medicine, and regulatory knowledge, we help clients make informed decisions that prioritize both patient safety and product success. Let’s work together to navigate drug safety challenges with scientific precision and strategic clarity.