FAQ

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FAQ

About Drugvigil

Drugvigil is a professional pharmacovigilance service provider headquartered in India, with limited operations in Tbilisi, Georgia. We help pharmaceutical companies and healthcare professionals maintain drug safety by providing end-to-end pharmacovigilance services — from ICSR case processing to aggregate report writing, signal detection, literature screening, and more.

We launched our operations in September 2022 in India. Our goal from day one has been to provide practical, cost-effective pharmacovigilance solutions that address the real pain points of pharmaceutical companies and CROs.

No. We currently operate as a sole proprietorship. Our founder is a pharmacovigilance expert who built the business on his extensive industry experience with the aim of solving client pain points directly. You can learn more about our founder by visiting his LinkedIn profile.

Yes. Our Georgia operations are legally registered under the name V-Tecq Solutions. We are currently in the process of merging this entity with Drugvigil to consolidate our operations under one brand.

Our Georgia operations are currently limited to translation services, regulatory submission support, and local literature search. All other case processing and writing services are handled from our India operations. We have plans to expand our Georgia services in the future.
ICSR Management

Yes. We offer comprehensive ICSR management from end to end — covering intake & triage, data entry, MedDRA coding, causality assessment, narrative writing, quality check (QC), and E2B submission to regulatory authorities. You hand us the case; we handle everything through to submission.

We recruit only qualified Healthcare Professionals (HCPs) for ICSR case handling — specifically Pharmacists, Dentists, and Physicians (Doctors). This ensures that every case is processed with the clinical understanding and medical judgement required for accurate adverse event assessment and narrative writing.

We currently operate as a focused, dedicated small team — which makes us the ideal partner for small-scale pharmaceutical companies and growing organisations. In terms of product scope, we are equipped to handle safety monitoring for up to 5 products at a time. This ensures every product receives the individual attention it deserves without compromising quality or timelines.

Yes. We have safety database support available to offer our clients. We work within your existing database environment (such as Argus or ARISg) and provide the necessary operational support to keep your case processing running smoothly without disruption to your current setup.

We have a dedicated team of experienced trainers who are well-versed in all aspects of ICSR case handling. Our trainers bring hands-on industry experience and ensure every team member is thoroughly trained on regulatory requirements, database operations, MedDRA coding, narrative writing, and quality standards before handling any client work.
Signal Detection

Yes. We have a signal detection tool that is built in-house — developed specifically for pharmacovigilance signal identification and validation. You can find a brief introduction to the tool on our Signal Detection page.

Yes. We offer end-to-end signal management — from signal detection and validation through to signal evaluation, documentation, and recommendation to the Marketing Authorisation Holder (MAH). Every step of the signal lifecycle is covered under our service.

We don't believe in empty claims — we let our tool speak for itself. If you are ready to see it in action, we are happy to schedule a live demo call where we walk you through exactly how our tool works and how effective it is in real-world signal detection scenarios. Contact us to book your demo.
Literature Screening

Yes. CLIScan is our in-house literature screening tool powered by advanced Machine Learning (ML) analytics. It is capable of intelligently identifying, filtering, and prioritising relevant articles from large volumes of published literature — significantly reducing manual effort while improving accuracy and consistency in pharmacovigilance literature monitoring.

CLIScan fetches articles from all major medical and scientific publishing platforms, including:
  • MEDLINE
  • PubMed
  • BASE (Bielefeld Academic Search Engine)
  • Springer
  • And several other major databases and publishers
This broad coverage ensures no relevant safety literature is missed across indexed and non-indexed sources.

Yes. CLIScan is capable of automatically retrieving monthly articles on schedule and making them available for review at any time. This means your literature monitoring runs continuously in the background — without manual intervention — and your team can access and review results whenever needed, keeping you consistently compliant with regulatory literature monitoring requirements.

Yes. CLIScan serves a dual purpose — it not only performs literature screening but also supports adverse event signal detection from the articles it retrieves. This means a single tool can cover both your literature monitoring compliance obligations and your signal detection workflow, making it a truly integrated pharmacovigilance solution.
Aggregate & Medical Writing

A PSUR (Periodic Safety Update Report) is a regulatory document that provides a comprehensive evaluation of a product's safety profile at defined intervals. It summarises cumulative safety data, benefit-risk information, and any new information that may affect the product's labelling. PSURs are required by EMA and other regulatory authorities.

A PBRER (Periodic Benefit-Risk Evaluation Report) is the ICH E2C(R2) harmonised format that replaces and extends the PSUR. It focuses on an integrated benefit-risk evaluation of the product during the reporting period, and is now the globally accepted standard for periodic safety reporting.

A DSUR (Development Safety Update Report) is an annual safety report submitted during the clinical development phase of a drug. It provides a comprehensive review of all safety information collected during the reporting period for investigational drugs. It is required by ICH E2F guideline and submitted to regulatory authorities overseeing clinical trials.

Timelines vary depending on the complexity of the product, the data lockpoint, and the volume of safety data. Typically, a PSUR/PBRER requires 4–8 weeks from data lockpoint to final delivery. We work closely with your team to agree on a realistic schedule that meets your submission deadline.
Local Pharmacovigilance (LPPV & QPPV)

An LPPV (Local Person Responsible for Pharmacovigilance) is the designated contact point in a specific country responsible for all pharmacovigilance activities and regulatory reporting obligations in that territory. Many markets — particularly in Europe and Asia — require MAHs to appoint a qualified LPPV.

A QPPV (Qualified Person Responsible for Pharmacovigilance) is a senior pharmacovigilance professional required by the EU for all Marketing Authorisation Holders. The QPPV has overall responsibility for the establishment and maintenance of the pharmacovigilance system and is the primary regulatory contact for all PV matters in Europe.

Yes. We provide local pharmacovigilance support including LPPV and QPPV services for companies operating in European markets, including Georgia. This includes acting as the local contact point, managing regulatory correspondence, and ensuring compliance with local PV obligations. Learn more about our LPPV/QPPV services.
Medical Information

A medical information call centre handles enquiries from healthcare professionals and patients about a company's drug products — covering topics such as dosage, interactions, contraindications, and off-label use. It also serves as the first point of contact for reporting adverse events, ensuring all spontaneous reports are captured and routed into the pharmacovigilance system.

Any adverse event reported through our medical information channel is immediately identified, documented, and triaged according to seriousness. The case is then entered into the safety database and processed as a standard ICSR — ensuring it meets all regulatory reporting timelines. No adverse event report is missed or delayed.
Social Media Mining

Social media mining involves monitoring online platforms — including Twitter/X, Facebook, Reddit, patient forums, and health communities — to detect adverse event reports and safety signals posted by patients and caregivers. With patients increasingly sharing their drug experiences online, this has become a critical source of real-world safety data.

We monitor a wide range of digital channels including Twitter/X, Facebook, Reddit, patient advocacy websites, health forums, and online communities. Coverage is tailored to the product and the therapeutic area, focusing on platforms where patients with that condition are most active.

We use an in-built, proprietary tool developed specifically for pharmacovigilance social media monitoring. It operates at a medium-to-advanced level, offering decent extraction and monitoring capabilities across all major social media platforms that patients commonly use to share their drug experiences and health journeys.
Pricing & Billing

No. Safety database licenses (such as Argus or ARISg) are not included in our listed service pricing. Database licensing will be offered once the final pricing has been concluded. Our pricing covers the services we perform only, and every quote is tailored to your specific requirements — volume, case type, and scope are all factored in.

ICSR pricing is structured on a per-case or per-unit basis, depending on volume and complexity. For aggregate writing, pricing is section-based or milestone-based. All pricing is agreed upfront with full transparency — no hidden charges. Visit our Pricing page for an overview or contact us for a tailored quote.

Yes. For clients with high case volumes or long-term engagements, we are open to discussing volume-based pricing arrangements. Please contact us to discuss your volume and we will propose the most cost-effective structure for your needs.

Yes. We welcome pilot arrangements so you can evaluate our work quality before committing to a full engagement. A pilot is a great way to assess our accuracy, turnaround time, and communication. Please contact us to discuss the scope and terms.
Databases & Technology

We have extensive hands-on experience with Argus (Oracle) and ARISg databases — the two most widely used safety database platforms in the industry. We use these for ICSR case entry, processing, follow-up management, narrative writing, and E2B submission. We are highly proficient in navigating both systems efficiently and accurately.

Yes. We work directly within your existing safety database environment. You provide us with the necessary access credentials and permissions, and we operate within your system — no data migration, no additional software installations, and no disruption to your current workflow.
Working with Drugvigil

Getting started is simple:
  1. Reach out via our Contact page or email us at info@drugvigil.com
  2. We discuss your requirements, scope, and timelines
  3. We sign an NDA and agree on pricing
  4. You provide database access and we begin work
You can also book a meeting directly on our calendar.

Yes. Every engagement begins with a signed NDA before any data or project details are shared. Client confidentiality is non-negotiable for us — all project information, patient data, and drug safety data are handled with strict confidentiality at all times.

We treat all client data with the highest level of confidentiality. Access to project data is restricted to authorised team members only. We follow strict data handling practices and comply with applicable data protection regulations. All communications are through secure, agreed channels.

We communicate via email as our primary channel, supplemented by video calls (Google Meet, Microsoft Teams, or Zoom) for project discussions and reviews. We adapt to whatever communication tools your team uses. Regular status updates are provided throughout the engagement to keep you informed.

Yes. Quality is built into every step of our workflow. For ICSR processing, every case undergoes a quality check (QC) before delivery. For aggregate writing, drafts are reviewed internally before submission to the client. We can also provide QC checklists and productivity/error reports upon request.

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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