Services

"Our commitment to excellence in pharmacovigilance extends beyond conventional services"

Consulting & Outsourcing Services

Guiding Your Path to Success: Consulting Excellence Redefined

Support Services

Elevating Your Potential: PV Retainer Services Unleashed

Industrial Training & Certification

Empower Your Team, Ensure Safety: PV Training Excellence

Clinical Safety & Compliance - Clini Resource

Clinical Safety & Compliance

  • SUSARs Management
  • Medical adjudication of SAEs
  • Analysis of similar events(AoSEs)
  • Safety Management Plans (SMPs)
  • Authoring IBs, CSRs & DSURs
  • Review of scientific publications
  • Signal review
  • Medical Monitoring

    • Post-Market Safety & Compliances

  • ICSR intake, processing, and submission
  • Global and local literature monitoring
  • Signal detection and management
  • Eudravigilance and MHRA Portal Services
  • PSMF/National PSMF

    • Post-Market Safety & Compliances - Clini Resource.jpg
    Medical Writing - Clini Resource

    Medical Writing

  • Benefit/Risk Reports
  • Aggregate reports- PSURs, PBRERs, DSURs, ACOs & PADERs
  • Risk management plans (RMPs) and REMS
  • Writing SOPs and technical documents – PV system setup
  • Writing product information, PILs, SmPCs, CCDS
  • Regulatory feedback

    • Regulatory Affairs

  • Regulatory Strategy Development
  • Regulatory Submissions
  • Compliance Management
  • Regulatory intelligence
  • Responses to Health Authorities

    • Regulatory Affairs - Clini Resource.jpg
    Medical Information MICC - Clini Resource

    Medical Information

  • Handling product Inquiry, Product complain & PQC
  • MICC
  • Emergency un blinding for Clinical trails
  • Subject Counselling
  • Customised responses to queries

    • Medical Devices & Veterinary pharmacovigilance

  • PMS system set-up
  • Incidents & Complaints Management
  • Field Safety corrective actions management
  • Annual PMS report & PSURs
  • Trend Analysis
  • Setting Up Veterinary Pharmacovigilance system and compliances

    • Medical Devices Pharmacovigilance - Clini Resource
    QPPV Services - Clini Resource.jpg

    Qualified Person for Pharmacovigilance (QPPV) Oversight

    Supporting Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) services in 20+ countries.

    PV Retainer Support Services

    Promoting the use of adept and highly trained pharmacovigilance (PV) retainer support for ensuring optimal safety and compliance standards.

    Medical Devices Pharmacovigilance - Clini Resource
    Clinical Safety & Compliance - Clini Resource

    Industrial Training & Certification

  • General PV / RA training
  • Topic specific training
  • Training on-site
  • Audit/Inspection readiness training
  • Training certifications

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