Expertise in nonclinical (preclinical) safety evaluation (toxicology, pharmacology, DMPK) of drugs and medical devices. Experience includes both small and large molecules (including monoclonal antibodies) covering a wide variety of therapeutic areas. Experienced with multiple modes of drug delivery (CNS, dermal, intra-articular, ocular, SC, PO, IV), including pumps, patches, and controlled release formulations. Consultant/contractor services include IND/registration planning, preparation, and regulatory interaction; study design/planning, lab selection, oversight, data interpretation/reporting, regulatory document preparation. Experienced with repurposing of old drugs. Guidance regarding formulation excipients, device materials, extractables and leachables, and API impurities. Provide expert opinion to support first dose for human studies. Experienced in working through difficult development challenges.Specialties: - Develop time and cost efficient IND strategy.- Provide strategic guidance and logistical support to emerging companies.- Develop action plans to deal with significant nonclinical safety issues.- Evaluation of nonclinical data for in licensing opportunities.