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Pharma services

    Panaceas specializes in evaluating and analyzing toxicological risks to human health. We offer integrated solutions in nonclinical toxicology for the clinical development of pharmaceutical drug candidates.

    Pharmacology/toxicology studies

    • Nonclinical safety and toxicology studies of drug candidates
    • In-vitro diagnostics (IVD) and in vivo toxicology studies
    • Toxicokinetic studies to determine absorption, distribution, metabolism, and excretion (ADME) strategy
    • Drug metabolism and pharmacokinetics (DMPK)
    • Contract research organization services (CRO)
    • Chemical & drug residue analysis
    • Drug test interpretation
    • Causation analysis and historical scientific data analysis

    Regulatory support

    • Drug approval process
    • Abbreviated new drug application (ANDA)
    • Pre-investigational new drug application (Pre-IND)
    • End-of-phase 2 (EOP2) drug application
    • New drug application (NDA)
    • Marketing authorization applications (MAA)
    • Pre-market approval (PMA)

    Clinical development support

    • Pre-clinical testing and R&D lab design
    • Special protocol assessments (SPAs)
    • Drug development

    Risk assessment

    • Biological materials analysis
    • Human hazard and risk assessment
    • Genotoxic impurities evaluation
    • Foreign materials examinations
    • Maximum tolerated dose (MTD)
    • No significant risk levels for carcinogens and maximum allowable dose levels (NSRL/MADL)
    • Health hazard evaluations (HHEs)
    • Health-based exposure limit (HBEL) report
    • Occupational exposure limits (OELs)
    • Permitted daily exposure (PDE) report
    • Predicted no-effect concentration (PNEC) identification
    • Dosimetry
    • Consumer claimed symptoms investigations
    • Pharmacovigilance

    Contact Panaceas

    Please contact Panaceas with any inquiries and partnership opportunities using the form. We’ll be in touch soon.

    hello@panaceas-consulting.com