Given its complex regulations and arguably strictest pharmacovigilance laws, pharmacovigilance system in Europe, governed by the EMA, may be the hardest to run and where you may need our help the most.
What can we do for you in Europe?
Tepsivo is the top choice in Europe and elsewehere. Now that’s a bold claim but we can substantiate.
Global Pharmacovigilance Services
When could you use our help?
See below some scenarios that you might be facing in Europe, or reach out to us directly if you look for pharmacovigilance consultancy and look to outsource your pharmacovigilance responsibilities in Europe.
You are planning to submit a Marketing Authorization Application (MAA) in EU
Whether this is your first MAA or you’re already experienced in going through the dossier submission, you might need assistance to ensure everything is in order, including your EU QPPV, PSMF, RMP, local contact persons and especially full PV system for when your application is approved.
We’re here to help: Contact Us
Your MAA is about to be approved and you need to build a full pharmacovigilance system
As a Marketing Authorization Holder in Europe, there are plenty of obligations in drug safety for you and it makes perfect sense to outsource activities such as EU QPPV role, Local QPPVs, Literature Screening and many others to a specialized provider like Tepsivo.
We can be either an addition to your internal team or function as your PV department in all of EU.
Learn more: Contact Us
You have a sudden resourcing need in one or more countries
Gaps in resources, for whatever reason, can occur and you may need a quick and reliable fix. Our network covers all European countries (+ most of the globe) and, using our automated PV processes, our local resources can be assigned to you within 2 weeks.
Tell us where your gap is: Contact Us
You have a PV provider and are considering an alternative
You are right to always expect only the highest standards of quality as well as appropriate pricing from your provider. It is okay to look around and see if there’s a better option for you. We are confident that Tepsivo can be the right alternative, especially if you value the same things we do: modernization, quality, and cost efficiency.
Reach out and we’ll talk more, no strings attached: Contact Us
You have recently undergone an inspection by a european health authority and received findings on PV insufficiencies
Inadequate PV activities performance? Lack of local representation? Gaps in processes? No worries, whatever it may be, we can help.
Get in touch with us and we’ll look at your findings and help you address them, promptly: Contact Us
Brexit has affected your pharmacovigilance obligations and you need support addressing these
Without doubt, Brexit is making a significant impact in our industry and while no one is clear how big this impact will turn out to be, MAHs may be expected to appoint an EU-based QPPV, and a local QPPV in the UK, incl. a local PSMF.
We will be happy to support you with any or all of these changes. Just reach out.
Is there a different situation applying to you and you are unsure what exactly your regulatory and PV obligations are?
No problem! Book a free 15-min consultation with us and we’ll figure it out together.
All our European PV services are run through our unique central pharmacovigilance platform.
Quality Management System
LCPPV / Local QPPV /
LSO Oversight platform
Streamlined safety reporting
& follow-up tool
Signal Management Tracking Tool
Safety Data Exchange
Automated audit trail of all actions
End-to-end management of
Adverse Event Intake Tool
Risk Management System Tracker
PSMF Management Solution
Automated PVA / SDEA
Dashboard for customers
Bosnia and Herzegovina
Trinidad and Tobago
Papua New Guinea
United Arab Emirates
Central African Republic
Democratic Republic of Congo
Republic of the Congo
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.