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Consulting Services

Preclinical to Clinical Path

  • 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

  • Quality management systems development and validation services

    • QC laboratories

    • GMP manufacturing of Biologics 

    • Non-GMP process development Laboratories

 

  • Quality compliance of projects outsourced to CDMOs

    • Client Audits of CDMO facilities 

    • Regulatory audit of CDMO sites

    • Quality oversight for CDMO activities

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

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