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Local Pharmacovigilance

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Local Pharmacovigilance Services

Global compliance. Local expertise.

Expanding into new markets? Regulatory authorities require a qualified local presence for pharmacovigilance oversight. We provide fully compliant Local Contact Persons and QPPV services in India and Georgia—eliminating the complexity of establishing your own local infrastructure.

What we handle:

  • Local safety report collection and regulatory submissions
  • Communication with national health authorities
  • Local literature monitoring in regional languages
  • Regulatory intelligence and compliance updates

Your single point of contact: We act as an extension of your global pharmacovigilance team—responsive, accountable, and aligned with your SOPs. Focus on your core business while we handle local regulatory obligations.

Local QPPV support
Authority liaison
Local literature

Coverage

Our Coverage & Capabilities

India. Georgia. Your regulatory obligations — handled.

Regulatory authorities require a qualified local presence in every market where your product is authorized. We provide fully compliant local pharmacovigilance support across our operational territories:

  • India (CDSCO) — Local safety data collection, ICSRs submission, regulatory correspondence, and periodic safety update reports for the Indian market.
  • Georgia (MoH) — Local contact person services, regulatory liaison, safety reporting, and compliance with Georgian pharmacovigilance requirements.
  • QPPV Services — Qualified Person for Pharmacovigilance acting as your designated local representative with full regulatory authority.
  • Regional Literature Monitoring — Local language literature screening for safety-relevant articles published in regional journals and publications.
  • Regulatory Intelligence — Continuous monitoring of local regulatory changes, guideline updates, and compliance requirements affecting your products.

Operations

How We Operate

Seamless extension of your global PV team.

Our local pharmacovigilance service integrates directly with your global safety operations through a structured onboarding and operational framework:

  • 01 Onboarding & SOP Alignment — We review your global SOPs, adapt them for local requirements, and establish communication protocols with your central PV team.
  • 02 Case Collection — Local adverse event reports collected from healthcare professionals, patients, and regulatory authorities through established channels.
  • 03 Local Regulatory Submissions — Timely submission of ICSRs and periodic reports to national health authorities in required formats and timelines.
  • 04 Authority Communication — Direct liaison with local regulatory bodies on safety queries, inspection support, and compliance matters.
  • 05 Audit & Inspection Support — Full documentation readiness and on-site support during regulatory inspections and internal audits.

Why Drugvigil

Why Drugvigil for Local Pharmacovigilance

Expand into new markets without the compliance overhead.

Setting up local pharmacovigilance infrastructure in a new market is expensive, time-consuming, and regulatory-complex. Hiring a local QPPV, establishing reporting processes, and maintaining ongoing compliance requires significant investment.

Drugvigil eliminates this burden. We act as your established local presence — already equipped with regulatory relationships, compliant processes, and experienced personnel.

  • Immediate market access without local infrastructure setup
  • Experienced local QPPVs with established regulatory relationships
  • Full alignment with your global pharmacovigilance system
  • Cost-effective alternative to in-house local PV teams
  • Continuous regulatory intelligence for your marketed products

We are Drugvigil (pharmacovigilance service provider) headquartered in India. We also do our limited operations at Tbilisi, Georgia. We help pharmaceutical companies and healthcare professionals improve the safety of their products.

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