Services

Everything we do, we do with the aim to elevate the science of pharmacovigilance and make the patient and drug safety a seamless endeavour.

NextPV Services covers the full spectrum of PV services including the strategic advice, PV system designing and implementation, outsourcing of all PV processes, EU QPPV and EU local QP network. We also provide audits, gap analysis and trainings.

NextPV delivers full-scope pharmacovigilance services for biotech and pharmaceutical companies operating in the EU. From setting up your PV system before first marketing authorization to managing ongoing post-marketing safety obligations, every service is delivered by senior PV professionals in compliance with EMA Good Pharmacovigilance Practices (GVP), ICH E2 and FDA guidelines.

Client profiles

Biotech or innovative pharma company based in or out of EU looking for a MAA in the EudraVigilance

"Do you need an EU presence, but you are not sure where to start?"

Biotech or innovative pharma company based in or out of EU with established EU presence.

“Do you need a strategic insight, gap analysis, audit or complex PV system optimisation?”

Generic and Biosimilar clients company based anywhere in the world

“Do you need to make your PV processes more efficient or support with strategic PV consultancy?”

Service providers or Clinical Research Organizations

"Do you need to extend your services for your clients with expert PV knowledge or execution?”

Technological companies

"Do you need consultancy and support for implementation of your solution into a complex PV system?”

Training Institutions or any Pharma or Biotech company

"Do you need delivery of PV trainings on any industry-related topic?”

Frequently Asked Questions About Pharmacovigilance Services

When should a biotech company start setting up pharmacovigilance for EU market entry?

Biotech companies should begin pharmacovigilance setup 12–18 months before their expected EU marketing authorization date. This allows time to appoint an EU QPPV, develop the Pharmacovigilance System Master File (PSMF), set up EudraVigilance access, validate a safety database, and establish all required SOPs. Companies that start PV setup at the time of MAA submission often face delays because EMA may request evidence of an operational PV system during the review process. NextPV typically completes full PV system setup in 3–6 months for new MAHs.

What is an EU QPPV and does every company need one?

A Qualified Person Responsible for Pharmacovigilance (QPPV) is a legally mandated role under EU Directive 2001/83/EC, Article 104. Every marketing authorization holder (MAH) with a product authorized in the EU must have an EU QPPV who resides and operates in the EU. The QPPV is responsible for the establishment and maintenance of the pharmacovigilance system, oversight of the safety profile of authorized products, and the PSMF. Many biotech companies outsource the QPPV role to specialized PV consultancies like NextPV rather than hiring in-house.

How much does it cost to outsource pharmacovigilance vs. building an in-house team?

For a biotech company with one EU-marketed product, building an in-house PV team (QPPV, safety officers, database, training, systems) typically costs EUR 300,000–500,000 per year. Outsourcing the same scope to a specialized PV provider like NextPV typically costs 20–30% less, because infrastructure and expertise are shared across a portfolio of clients. The exact cost depends on product complexity, ICSR volume, and the scope of services required. We offer a free PV gap analysis to provide a tailored cost estimate.

What happens during a pharmacovigilance inspection by EMA or a national competent authority?

An EMA or NCA pharmacovigilance inspection typically lasts 3–5 days and reviews your entire PV system against GVP requirements. Inspectors examine your PSMF, SOPs, training records, ICSR handling processes, signal management activities, PSUR submissions, safety database validation, and QPPV oversight documentation. Common critical findings include inadequate signal management processes, missed reporting deadlines, and insufficient QPPV oversight. NextPV has supported 20+ inspections with a 100% success rate — zero critical findings.

What is a PSMF and why is it important?

The Pharmacovigilance System Master File (PSMF) is a mandatory document described in EMA GVP Module II (EMA/838713/2011). It provides a detailed description of the pharmacovigilance system used by the MAH, including organizational structure, quality system, SOPs, database descriptions, contractual arrangements, and process descriptions. The PSMF must be maintained continuously and made available to inspectors upon request. An incomplete or outdated PSMF is one of the most common inspection findings.

Can NextPV help if we already have a PV system but need improvements?

Yes. Many of our clients come to us with an existing pharmacovigilance system that needs optimization. We start with a comprehensive PV gap analysis — comparing your current system against EMA GVP requirements — and deliver a prioritized remediation plan. Common areas for improvement include signal management processes, PSMF updates, training program gaps, and safety database validation. We can also provide ongoing support for specific activities (e.g., PSUR writing, case management overflow) without taking over your entire PV function.

What is EudraVigilance and do we need it?

EudraVigilance (EV) is the EU's centralized database for reporting suspected adverse reactions to medicines. Under Regulation (EU) No 520/2012, every MAH with an EU-authorized product must register for EudraVigilance access and submit Individual Case Safety Reports (ICSRs) electronically. You also need to maintain product information in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). NextPV handles the full EudraVigilance lifecycle — registration, ICSR submission, XEVMPD maintenance, and EVDAS signal screening.