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  • CEO/Principal

    Lucia Mokres

    13 years of experience 0 projects USA Research & Development
    MDR compliant clinical documentationProject managementregulatory submissions Clinical AffairsClinical OperationsDeviceMedical AffairsPharmbio Start UpRegulatory 21 CFR Part 11AE/SAE ReportingAnnual ReportBfArMBiopharm Start UpBusiness IntelligenceCardiovascularCFR Part 210CFR Part 211CFR Part 312CFR Part 320CFR Part 50CFR Part 56CFR Part 58CFR Part 812CFR Part 820ClinicalClinical development planClinical Evaluation ReportsClinical Program ManagementMedical AffairsMedical DevicePharmbio Start UpsProject managementRegulatoryRegulatory & Medical WritingRegulatory Intelligenceregulatory publishing
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    SUMMARY

    I founded Araneae Biotech Consulting to provide savvy, timely clinical and business lifecycle support, enabling exceptional success for innovative Life Science companies. By leveraging my extensive cross-functional expertise, I help Life Science companies to efficiently develop and de-risk their assets in the face of a continuously changing regulatory, commercial, and investment environment. In plain English – I’ve been there, done that, and I know what it’s like to need someone in your rolodex who will not only get the…