Pharmacovigilance
done the modern way

It’s 2022. Let’s bring PV into it.

Pharmacovigilance solutions outsourced the modern way. In all we do, we’re obsessed with efficiency and creating value for customers, so hard to come by in PV.

Whether you need to set up and maintain a new pharmacovigilance system or simply look for new ways of doing things, we’re here to help. With the global Tepsivo PV system in 150+ countries, you will get to enjoy 100% compliant, automated, and most time & cost-efficient solution you can find (we dare you).

If you believe PV can be modernized and liberated of endless admin tasks and obsolete processes, let’s talk.

Navigating the complex regulatory waters around the world. With our network of regulatory experts, we provide candid guidance on how to skip bureaucratic hurdles.

If you look to get your medicine to global markets and make sure it stays there, you need the right global or local expertise to help you with the regulators to submit marketing authorization applications, renewals, or many different variations and other documents. Ideally someone with your interests at heart.

The days of RA consultants motivated by charging out long hours are over, reach out for honest advice.

Smart digital automation solutions to help you focus on what matters. Finally, there is a truly streamlined Pharmacovigilance system reducing all unneccessary admin work.

The unique in-house built Tepsivo Platform and safety database are the cornerstone of our success. Central point of automation across all functions, with modules ranging from end-to-end PV to niche utilities such as local contact person for pharmacovigilance management or automated regulatory intelligence.

Forget worrying about tracking, keeping audit log, endless back-and-forth, and too many other redundant tasks. Automate with us.

What are we all about?

We are a young company challenging the status quo with a fresh new take on how to provide the best possible services in Pharmacovigilance and Regulatory Affairs.

See why we think we’re different:

MODERN

Established in 2020, we truly are what it means to be a present-day company. There are no old-school practices here; we didn’t even exist in the old school.

Tepsivo is digital, efficient, and tech-savvy.
Let’s start applying contemporary methods into an industry traditionally slow to adapt to change.
We can finally transform Pharmacovigilance and Regulatory Affairs into a modern-day business.

Discover more on our story

 

Cost-efficient

As crucial as drug safety monitoring is, we also acknowledge PV as what our clients ultimately view it to be: a cost center. While you need highly qualified experts, you always need to pay the right price.

We can substantially decrease your PV and RA budgets through our streamlined processes and automated tools; simply by focusing on what matters instead of unneeded time intense tasks. Fewer work hours equal smaller invoice. That is what cost-efficient means to us.   

See more on our pricing

Effective

At our home in Finland, “tepsivä
” means “effective”. That is the inspiration for our name, and it is what defines us best.

In all we do, we apply our no-nonsense attitude with the aim to be efficient, eliminating or automating all unnecessary work to optimize our clients’ global operations. Our clients enjoy a service that is streamlined, digital, and well, effective.

See how we automate our processes

 

Global

You can use our services anywhere in the world. We can provide you with local regulatory affairs and pharmacovigilance experts in over 150 countries of the world.

Whether it’s our resources or your internal staff, the entire global operations is managed centrally through our automated Tepsivo Platform, which removes classical admin overhead associated with managing global projects. Let us take that pain away from you.

See more on our global operations

 

OK, all this may sound a little too boastful. But we can prove it.

Contact us and see for yourself

Pharmacovigilance

services redefined

We have reimagined the ways PV activities are done. Do we have something revolutionary and completely disruptive?

Honestly, no. We are just a little better at using modern technologies and practices that are already available but had been omitted in the PV industry. Until now.

We would love to tell you more and especially show you how we operate. Let’s talk. No strings attached.

Countries covered

Admin costs

Average setup time

Learn more

No matter what you need, we’ll answer in less than 24 hours.

Honest Regulatory Affairs Advice

When it comes to regulatory expertise, you need consultants who want to help you and not themselves. It’s easy to come across opportunists and so-called experts who take their customers for a ride and look for ways to spend their hours they charge out. Such thinking has no place in today’s world.

Thanks to our obsession with efficiency, seeking ways to justify high number of hours goes completely against our nature. With us, you can rely on honest advice and help meeting your regulatory needs in the most effective and correct way possible.

Reach out and we’ll help you alleviate your bureaucratic pains.

Automated pharmacovigilance solution

Tepsivo Platform – saving you time and money

What is it?

One central place for your entire pharmacovigilance system. Onboard your drug safety personnel onto our platform, whether internal or as outsourced pharmacovigilance support by Tepsivo, and enjoy the benefits of truly modern, digital PV operations .

With our platform, you can finally forever forget about the pile of trackers, audit logs, time-intense data entry, hours spend on reporting and reconciliation, and many other endless boring activities so typical within PV.

Why did we develop it?

We saw a need in the PV industry for a long-time pending transformation into a modern-day business. We were unhappy about the slow pace of adopting automation and digitalization within pharmacovigilance and we decided to change it.

That’s why Tepsivo exists and why we built our Tepsivo Platform, created with one simple mission: to make all PV activities easier, quicker, higher quality, and more cost efficient. If you think there’s a better way to do PV, Tepsivo Platform is the place to start.

Let our automated platform take the bother away from you so your pharmacovigilance teams can focus on what truly matters in our industry: science.

Integrated modules

Quality management system

LCPPV / Local QPPV
/ LSO Oversight platform

Streamlined safety reporting
and follow-up tool

PSUR tracker

Signal management tracking tool

Safety data exchange
agreement management

Automated audit trail of all actions

COMPLIANCE TRACKER

Adverse Event Intake Tool

End-to-end management
of pv personnel

Literature monitoring
streamlined management

Risk management system tracker

PSMF Management solution

Automated PVA/SDEA
Partner reconciliation

Dashboard for customers

CAPA management

Full transparency. 100% Compliance and Inspection Readiness. Highest Quality.
Rapid speed. No admin Overhead. Minimal Cost.

All in one place. All in Tepsivo platform.

Try yourself!

Instant access to our digital platform

We are convinced that the Tepsivo automated solution is a game-changer. But here’s the deal, book a demo and you can make your own opinion.

Pricing uncovered

Forget waiting for as simple things as a quote for your enquiry. We will provide you with basic calculations in no time.

And what is more, we fully reveal how the calculation is done.

And so…what brings YOU here?

Let us guide you right where you need!

Looking to outsource Pharmacovigilance Services?

You’re in the right place! Submit your enquiry here: Submit RfI/RfP

Entering the EU market and need navigating through the complex regulations?

Europe is our stronghold and we’re happy to lead you through the complex regulations here.

Have a look at our EU services offer or book your 15-minute consultation with a PV professional.

Interested in improving your processes with modern digital products?

That is the way to go! Have a look at our automation products offer or contact us directly.

IS Brexit affecting your pharmacovigilance set-up?

If you need an EU-based QPPV, establish a local UK QPPV, maintain a local UK PSMF, or face other Brexit-related issues, we are happy to look at your situation and help.

Get in touch with us

In need of a quick ad hoc consultancy?

Our PV experts are here for you, 15 minutes for free:

Book your consultation

Unsure about regional or local Regulatory and Pharmacovigilance requirements around the world?

Have a look at our Services or Contact us directly for more information.

Unclear what to do with regulatory submissions around the world?

No need to worry. Tell uswhat you’re dealing with, and we’ll help you come up with a solution. You may find our services or productsare the right painkiller for your regulatory affairs headaches.

Not exactly sure what you need?

No problem, drop us a message and we’ll contact you to find out.

Contact us

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.

Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | [email protected]  | +358 402 204 698 | Privacy policy