Tiresias Consulting, LLC jobs and careers

About Tiresias Consulting, LLC

Accelerate your path to approval with expert safety strategy and regulatory insight. Orphan & Rare Disease Drug Development • IND-enabling nonclinical program design and gap analysis • Regulatory strategy (Fast Track, Breakthrough, Orphan Designation) • Disease model evaluation and regulatory alignment • Regulatory submission support (e.g. IND, BLA) • AAV gene therapy safety assessment (GLP toxicology and biodistribution) Veterinary Drug Development • Target Animal Safety strategy and FDA/CVM-concurred study design • Specialized studies including vaccine response and avermectin-sensitive collie safety • P-glycoprotein (MDR1) interaction assessment • Human user safety and risk assessment • Integration of safety strategy with CMC and efficacy programs • Global regulatory strategy and submissions (US, EU, Canada, Japan) Cross-Disciplinary Expertise • Impurity risk assessment and qualification • Study design, placement, monitoring, and reporting • Safety data interpretation and strategic risk mitigation • Regulatory writing: safety summaries, briefing packages, submission documents • Long-term program leadership and integration of safety into development strategy • Relationship management with contract laboratories and external collaborators