EU PV Regulatory Intelligence news: EU Commission Implementing Regulation 2025/1466 Other
guides

Extensive experience & recognized global PV experts

20+

Successful inspections

1200+

happy attendees of pv trainings

60+

dia/ema trainings

Added value projects and challenging situations

The added value of our comprehensive services is that we make even the most complex situations easy for our clients. We have worked on pre- and post-inspection projects, in- and out-sourcing scenarios as well as complete new build-up of MAH PV QMS’s creation and implementation.

Expert implementation of computerized systems

The NextPV team can assist you in implementing automated PV tools to improve control and task execution, optimize PV operations, and save time. In addition to many other areas, we have practical experience with safety databases, signal systems, literature surveillance, and many more.

Execution of well mastered PV activities

In addition to our added value services, we are prepared to assist you in carrying out routine PV tasks enhanced by our unique experience, unconventional thinking and expert understanding of the legislation. Our goal is to leave the pharmacovigilance environment in a better state than we found it, protecting patient safety, compliance of Market Authorisation Holders or Sponsors, and the confidence of all parties involved in drug safety.

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

"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?”

2021

Company established with a clear vision to offer top tier PV services and become the leading innovator in the area of PV

2022

Successful establishment of offices in the modern center of Prague, extension of PV team and delivery of remarkable projects at various clients

2023

Multiple Assignments focused on challenging pre- and post- inspection complex situations at numerous MAHs

2023

Launch of PV Master Suite, navigating towards knowledge sharing and education among various PV/drug safety professionals

2024

Creating educational PV content on social media (LinkedIn) and expanding the website with an educational background gathered under the Safety corner. Diverse implementation of signal databases and launch of internally housed AI tools.

MISSION

Offer top tier pharmacovigilance services and significantly improve the drug and patient safety, leveraging the systematic research, using the best preventive practices at all levels, and ensuring reliable risk management.

VISION

Become the leading innovator in the area of pharmacovigilance, by implementing current and advanced technology tools and utilizing the approved regulations.

About us

We understand all aspects of pharmacovigilance, have extensive experience and can prove it!

Jan Kolouch

CEO

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management.

Vojtěch Kvita

CVO

Qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas.

Common questions about pharmacovigilance consulting

What is pharmacovigilance consulting?
Pharmacovigilance consulting provides biotech and pharmaceutical companies with expert guidance and operational support for drug safety activities required by regulators. This includes setting up pharmacovigilance systems, appointing qualified persons (QPPV), managing adverse event reporting, conducting signal management, preparing regulatory documents (PSURs, RMPs), and ensuring inspection readiness. Consulting is especially valuable for biotech companies entering the EU market for the first time or scaling their PV operations.
Why do biotech companies outsource pharmacovigilance?
Biotech companies outsource PV because building an in-house pharmacovigilance function requires significant investment in specialized personnel, validated systems, and regulatory expertise. For companies with 1–3 products, outsourcing to a specialized PV partner like NextPV is typically 20–30% more cost-effective than in-house operations, while providing access to a broader range of expertise (QPPV, signal management, regulatory writing, EudraVigilance) than any single hire could offer.
How long does it take to set up a pharmacovigilance system for EU market entry?
With NextPV, a full PV system setup for EU market entry — including QPPV appointment, PSMF development, EudraVigilance registration, safety database validation, SOP development, and staff training — typically takes 3–6 months. Starting from scratch in-house without prior PV infrastructure takes 12–18 months. We recommend starting PV setup at least 12 months before your expected marketing authorization date.
Does NextPV only work with EU pharmacovigilance requirements?
While our core expertise is EU pharmacovigilance (EMA GVP, EU Directives, EudraVigilance), we also support clients with FDA safety reporting requirements (21 CFR 312/314), ICH E2 guidelines, and global pharmacovigilance obligations. Many of our biotech clients operate in both EU and US markets, and we coordinate PV activities across jurisdictions.
What does a PV gap analysis involve?
A PV gap analysis is a systematic review of your pharmacovigilance system against EMA GVP requirements. We assess your PSMF, SOPs, quality system, training records, safety database, signal management processes, and reporting workflows. The output is a prioritized report identifying compliance gaps with specific remediation recommendations and timelines. NextPV offers a free initial PV gap analysis consultation.

Contact us

Submit your question or RFI/RFP