• CELUI Regulatory Services

    CELUI Regulatory
    Services

    Provides end to end Regulatory services for all dosage form & to the Pharmaceutical and Healthcare Industries for regulated.

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  • CELUI Pharmacovigilance Services ensures

    CELUI Pharmacovigilance
    Services ensures

    That all regulatory compliance are met as per regulatory guideline for clients product.

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  • Independent Auditing and sponsor oversight

    Independent Auditing
    and sponsor oversight

    For clinical trial studies are ICH GCP requirement.We also offer Risk Based monitoring as per US FDA Guidance

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  • Company WHY CELUI
  • WHY CELUI

    • End to End Services for Regulatory Affairs and Pharmacovigilance Activities
    • Presence of Local Expertise in EU/USA/CIS markets for Regulatory and Pharmacovigilance
    • Independent Monitoring, Auditing and Remote Monitoring under same umbrella
    • Timely and cost effective services
    • Highly experienced project management team
    • Robust Quality Management System for all activities

Our Services

Regulatory Services

Regulatory Services

Regulatory dossier preparation and filling. Local FDA Licensing, eCTD submission, Art work and Label preparation.
Pharmacovigilance

Pharmacovigilance

End to End PV services, RMP/PSUR/PSMF/SDEA preparation. Local QPPV service
Clinical Research

Clinical Research

Clinical Research, Independent Auditing, Remote Monitoring, Medical Writing.