NUES, INC

Capabilities

• Pre-clinical Development • Phase I-IV Trial Support • Regulatory Affairs • Investigational New Drug (IND) Preparation & Filings • 510(k) • Trial Design • Biostatistics • Medical Writing & Communications • Site Monitoring • Compliance Audits • FDA Readiness Audit • Risk Management • Patient-focused Recruitment • SOP Development & Implementation • Risk Evaluation and Mitigation Strategy (REMS) • Pharmacovigilance • Site Management • eCTD Dossiers & Publication • Computer-aided Drug Design (CADD) • Pharmacokinetics & Pharmacodynamics (PK/PD) • Drug Metabolism and Pharmacokinetics (DMPK)