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

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

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 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

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

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.