End-to-End Pharmacovigilance & Drug Safety

End-to-End Pharmacovigilance & Drug Safety
Product Description

Client-Centric PV System Schedule M - Compliant PV Global Literature Surveillance ICSR Processing & Reporting Aggregate Report Management (PSUR/RMP/PADER/ASR/DSUR) Signal Management 24/7 Safety information Centre & PV Case Intake Regional PV Services (EU/UK/ROW) QPPV/LRPV/PVOIC Services Safety Monitoring in Clinical Development Global Audit and Inspection Support

Makromed LLC

  • Country/Region:
    India
  • Founded:
    2013
  • On CPHI since:
    2026
  • Employees:
    25 - 49
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
Regulatory Affairs

Makromed LLC

  • Country/Region:
    India
  • Founded:
    2013
  • On CPHI since:
    2026
  • Employees:
    25 - 49
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
Regulatory Affairs

More Products from Makromed LLC (5)

  • GMP Audit Services

    Product GMP Audit Services

    Manufacturing Site Audits (Finished dosage forms, API, distribution unit, Labs) Vendor Qualification Audits (API suppliers, Excipient suppliers, Packaging suppliers) Specialized GMP Audits
  • Global and Local Pharmacovigilance Service

    Product Global and Local Pharmacovigilance Service

    Client-Centric PV System

    Global Literature Surveillance

    CSR Processing & Reporting

    Aggregate Report Management

    (PSUR/RMP/PADER/ASR/DSUR)

    Signal Management

    24/7 Safety information Centre & PV

    Cas...
  • MakroEase - Database

    Product MakroEase - Database

    Real-Time Tracking for Product Registration & Approval

    Customizable Analytics & Reporting

    Global Dossier Flexibility

    PV Regulatory Connect

    Local ADR Collection and Reporting

    PSUR Submission Tracking

  • Registration, Distribution and Networking Services

    Product Registration, Distribution and Networking Services

    Registration, Distribution and Networking Services


    Drug & Food Supplement Registration

    Import and Custom Clearance

    Tariff Planning and Optimization

    Local Review and Authority Communication
    Regional Sales & Mar...
  • Regulatory Affairs Services

    Product Regulatory Affairs Services

    Regulatory Legal Framework

    Regulatory intelligence

    Dossier Preparation and compilation

    Dossier Validation

    Safety/Efficacy:  bridging justification

    Labelling & Artwork

    Lifecycle Management: Preparation and sub...

Makromed LLC resources (1)

  • Video Corporate Presentation

    Makromed is a global service provider specializing in end-to-end solutions across Regulatory Affairs, Pharmacovigilance, and Healthcare Compliance for pharmaceutical, and Nutraceuticals companies.