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Drug safety

Pharmacovigilance

Pharmacovigilance (PV) means watching for side effects once a medicine is in use. Materiovigilance is the same work for medical devices. We do both, for companies that hold a licence to sell in India and abroad.

What it is

In one sentence

We collect reports of side effects, check each one, look for new risks, and send the reports the regulator asks for.

Who it is for

Safety, regulatory and quality heads at companies that hold a marketing licence (the licence to sell a medicine or device). This includes small companies with only one or two products.

Problems it solves

Common safety gaps, and how we close them

  • Thinking a small company is exempt

    Some companies with few products think they do not need a full safety system. They do. We set one up that fits the size of your portfolio.

  • Outsourcing, then losing sight

    The licence holder stays responsible even when a vendor does the work. We help you check your vendor, and we write clear contracts on who sends what, and by when.

  • Reports missing key facts

    A case with no batch number, dose or outcome is hard to assess. We follow up with the reporter and record what was asked and when.

What you get

Deliverables

  • A safety system set up for your products: the PSMF and the SOPs (written step-by-step procedures)
  • Case intake from patients, doctors, pharmacists and carers
  • Case processing and medical review of each report
  • Coding with MedDRA for medicines and IMDRF terms for devices
  • Regulatory reports in E2B(R3) and CIOMS formats
  • Signal detection and benefit-risk assessment
  • Periodic safety reports: PSUR or PBRER, and DSUR
  • Risk management plans and risk minimisation plans
  • Support for safety label changes, safety letters and recalls
  • Materiovigilance for medical devices
  • A named PV officer for India (PvPI) and for device vigilance (MvPI)
  • Mock inspections and inspection support

How it works

How we run your safety work

  1. Set up the system

    We write or update your PSMF and SOPs. We agree who does what, and how fast.

  2. Take in reports

    We receive side-effect reports from patients, doctors, pharmacists and published papers. We log each one the day it arrives.

  3. Check each case

    A trained safety associate enters and codes the case. A medically qualified reviewer judges how serious it is and whether the product caused it.

  4. Report and look for patterns

    We send serious cases to the regulator within the legal deadline. We look across all cases for new risks, and write the periodic reports.

  5. Stay ready for inspection

    We keep your records, training files and corrective actions up to date. We run mock inspections before the real one.

Regulators and standards

Rules we work to

We name the rule behind each report we send.

CDSCO (India)
The Central Drugs Standard Control Organisation. India's national regulator for medicines and medical devices. Every licence holder must run a safety system it can inspect.
PvPI
The Pharmacovigilance Programme of India. The national programme that collects side-effect reports for medicines. We can act as your named PV officer for it.
MvPI
The Materiovigilance Programme of India. The national programme for problems with medical devices. We can act as your device vigilance contact.
ICH safety guidelines
International rules for safety data. They set the E2B(R3) format for case reports and the content of the PBRER and DSUR.
EU MDR
The European Union's Medical Device Regulation. It sets the rules for device safety reports and post-market follow-up.
Terms explained
PSUR or PBRER: a report, sent at set times, that sums up a medicine's safety and weighs its benefits against its risks. DSUR: the same kind of yearly report for a medicine still in trials. PSMF: the master file that describes your whole safety system. Signal detection: looking across many reports for a new risk, or a known risk that is getting worse. Materiovigilance: safety monitoring for medical devices. ICSR: one report about one patient. MedDRA: a standard list of medical terms for coding side effects.

Proof

Are you a patient, carer or health worker? Please see how to report a side effect.

FAQs

Questions we are often asked

We are a small company with only two products on sale. Do we still need a full safety system?

Yes. India's rules give no exemption for small companies or small portfolios. Every licence holder needs a working safety system, a master file, trained staff and written procedures. This is true for two products or two hundred. A side effect harms a patient the same way, whatever the size of the company.

We have outsourced all our safety work to a vendor. Are we still responsible if they miss a deadline?

Yes, fully. You cannot hand over the licence holder's duty. If your vendor sends a serious report late, the regulator acts against you, not the vendor. That can mean a show-cause notice, a suspended product or an import stop. Your Safety Data Exchange Agreement (the contract on who shares what safety data, and when) gives you rights against the vendor. It does not protect you from the regulator. So check your vendor often, audit them, and set clear deadlines in the contract.

Do you handle safety for medical devices?

Yes. This is called materiovigilance. We take in device problem reports and report to MvPI. We support field safety corrective actions (steps such as a recall or a fix sent to users). We also write post-market surveillance plans (plans to keep watching a device once it is sold) and periodic device safety reports for CDSCO and EU MDR.

Can you be our named PV officer?

Yes, for India. We can be your named PV officer for PvPI and your device vigilance contact for MvPI.

How do you use AI, for example in literature searches?

AI tools help us search medical papers and safety databases such as PubMed, Embase, VigiBase and FAERS. They help us screen, sort and summarise what we find. A trained person checks every result and makes every safety judgement. The AI never decides alone.

How fast do you handle a case?

We log each report the day it arrives and sort it by seriousness. Serious cases go to the regulator within the legal deadline, which can be as short as 7 or 15 calendar days.

Which safety database do you use?

We can work in your company's own safety database, or in our own validated safety database.

Can you move our old cases into a new database?

Yes. We move the data, then check that every case arrived complete. We keep the test records the regulator expects, known as IQ, OQ and PQ (checks that the system is installed right, works right, and works right with real data).

How big is your safety team?

We have a core team of trained safety associates. A medical director and our PV officer-in-charge lead it, with drug-safety doctors and senior pharmacists. We add people for busy times, such as a launch or a periodic report.

I am a patient. How do I report a side effect?

Please email safetyreporting@trialguna.com or call +91 88671 25414 (Mon – Fri, 9:30 am – 6:30 pm IST). If someone is very unwell, see a doctor or go to a hospital first.

These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.

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