APIs in Portfolio

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Local Monitoring Resources

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Expertised PV documents

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Submitted Cases

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VIGILANCE

  • Pharmacovigilance

    • Set up and implementation of Pharmacovigilance System
    • Development and maintenance of Pharmacovigilance System Master File (PSMF)
    • 24/7 availability as of Qualified Person for Pharmacovigilance (QPPV) and Local contact person for Pharmacovigilance (Local QPPV)
    • International and Local Literature Review
    • Regulatory Intelligence Services
    • Authority Website Monitoring
    • Product Complaints Management & Reporting
    • Adverse Events case Processing & Reporting
    • Signal detection and Management
    • Aggregate reports (PSUR/ PBRER/ PADERs)
    • Preparation/maintenance of Risk Management System (RMS), Risk Management Plan (RMP) and Risk Minimisation Activities
    • Direct Healthcare Professional Communication (DHPC) management
    • Safety Data Exchange Agreements (SDEA) preparation and maintenance
    • Training
    • Supporting of Expertise process of PV System by NCA
    • Audit and inspection readiness

  • Nutrivigilance

    • Appointment of Local Contact Person for Food Supplement Vigilance
    • Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
    • Submission of serious adverse reactions to the manufacturer
    • Periodic search of safety information of food supplement products in scientific literature
    • Food supplement Product Safety Report
    • Signal Detection and Management

  • Cosmetovigilance

    • Appointment of Local Contact Person for Cosmetovigilance
    • Comprehensive management of adverse events of cosmetic reported by consumers, health professionals or authorities
    • Submission of serious adverse reactions to the manufacturer
    Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
    • Cosmetic Product Safety Report
    • Signal Detection and Management

  • Veterinary Vigilance

    Under development

  • Materiovigilance

    • Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
    • Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to manufacturer
    • Monthly compliance and status reporting
    • ADE and MDI Reconciliation
    • Preparation of Periodic Summary Reporting
    • Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
    • Writing and/or reviewing Standard Operating Procedures
    • Periodic literature search in scientific literature to identify safety information and adverse reactions of food supplement products

Functional Service Provider (FSP) In Clinical Study

  • Safety Management

    • Individual Case Safety Report (ICSR) Processing (Medical Evaluation of Cases)
    • Safety Database
    • Serious Adverse Event (SAE) Reconciliation (Necessary for Regulatory Authorities (RA) Submission)
    • Serious Adverse Event (SAE) Narratives Preparation
    • Case Report Form (CRF) and line-listings safety review (To address any site concerns regarding health state of participants)

  • Medical Writing

    • Study Abstracts
    • Clinical Protocols
    • Informed Consent Forms
    • Patient Information Sheets
    • Case Report Form
    • Clinical Study Reports
    • Risk Management Plan /Risk Evaluation and Mitigation Strategy (RMP/REMS)

  • Medical Coding

    • MedDRA Terms Coding (using the latest version of MedDRA dictionary)
    • WHO Drug Terms Coding
    • Coding Consistency Review (in accordance with MedDRA, WHO Drug and other specific recommendations)

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