Leiam Consultancy
Consulting Services
Preclinical to Clinical Path
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Preclinical-to-IND strategy
Plan, Budget, Schedules
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Design and execution of IND enabling preclinical studies
Toxicology
Pharmacokinetics
Efficacy
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Regulatory dossier submission Drafting, Reviewing, Tracking of ICH compliant package
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Early Phase clinical study planning and execution
Quality and Compliance for Biomanufacturing
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Quality management systems development and validation services
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QC laboratories
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GMP manufacturing of Biologics
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Non-GMP process development Laboratories
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Quality compliance of projects outsourced to CDMOs
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Client Audits of CDMO facilities
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Regulatory audit of CDMO sites
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Quality oversight for CDMO activities
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Facility Design and Build
QC analytics
Bioprocess Development
GMP manufacturing
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Project strategy and workflow
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Diligence for identifying and appointing design firms and contractor