Terms of service

Last updated: 4 October 2026.

1. Who we are

These terms are an agreement between you and Bogdan Parau, Cluj-Napoca, Romania ("Kreastel", "we"). Contact: hello@kreastel.eu.

2. What Kreastel is — and is not

Kreastel is a planning and oversight aid for people responsible for pharmacovigilance at marketing authorisation holders. It records due dates, owners and statuses of regulatory obligations and produces reminders and exports.

Kreastel is not:

• a safety database or a system for receiving, processing or reporting adverse events;
• a document management system or the system of record for your quality documents (SOPs, PSMF, agreements, training records), which remain in your own quality management system;
• a source of regulatory advice, a submission tool, or a substitute for the marketing authorisation holder's own pharmacovigilance system and its qualified person.

You remain solely responsible for your pharmacovigilance system, for verifying every date and obligation against authoritative sources (including the EURD list as published by the European Medicines Agency and the conditions of your marketing authorisations), and for all regulatory submissions and deadlines. Kreastel displays and computes; you decide.

3. Prohibited data

You must not enter into Kreastel any individual case safety report, any personal data of patients, consumers or reporters, any health data about identifiable persons, or any data you are not entitled to share with a processor. We may suspend a workspace that contains such data and will notify you.

4. EURD list and computed dates

The EURD list content shown in Kreastel is reproduced from the European Medicines Agency's published list, with the version and publication date stated. Dates that Kreastel computes (submission dates, next data lock points, reconciliation dates, review dates) apply rules stated on the page or in the documentation; they are aids to planning. The authoritative source is always the list as published by the Agency and the terms of your marketing authorisation. Changes in the list may be shown before they take effect; the effective date shown is computed from the publication date and may require your own verification.

5. Accounts and workspaces

You must provide a working e-mail address and keep your access to it secure. A workspace owner is responsible for who they add to the workspace and for their roles. During the beta, access is by invitation code; we may limit the number of workspaces, users and records on free plans.

6. Your data

You retain all rights in the data you enter. You can export it as CSV at any time and may request deletion of a workspace. We process register contents only to provide the service, under the data processing agreement available at kreastel.eu/dpa. We may compile anonymised, aggregated statistics about use of the service that do not identify any customer or entry.

7. Audit trail and no deletion of records

The application records every change to a register entry (user, time, old and new value) in a log that cannot be edited by anyone, including us, and register entries are archived rather than deleted. This is a feature of the service; by using it you accept that this record exists for the life of the workspace.

8. Availability and changes

We aim to keep the service available at all times but do not guarantee uninterrupted operation, particularly during the beta. We will announce changes that affect documented requirements of the validation kit at least 14 days in advance where practicable, and publish release notes for every version. We may modify or discontinue features; if we discontinue the service we will give at least 60 days' notice and the ability to export your data.

9. Beta

While a workspace is labelled "beta", the service is provided for evaluation, free of charge, without any service level, and may contain errors. Feedback you give us may be used to improve the service.

10. Fees

Not applicable during the beta. When paid plans are introduced, fees, billing period and the merchant of record will be stated on the pricing page and in the checkout, and these terms will be updated.

11. Warranties and liability

The service is provided as is. To the extent permitted by law, we exclude all warranties, and in particular we do not warrant that any computed date, reminder or export is complete, correct or timely.

To the extent permitted by law, our total liability arising out of or in connection with the service, whatever the legal basis, is limited to the fees you paid to us in the twelve months before the event giving rise to the claim (and to €100 where no fees were paid), and we are not liable for indirect or consequential loss, including regulatory sanctions, late or missed submissions, inspection findings, loss of authorisation, loss of business or loss of data — the avoidance of which remains your responsibility as set out in section 2.

Nothing in these terms limits liability for intent, gross negligence, death or personal injury, or any liability that cannot be limited under applicable law.

12. Acceptable use

No attempts to access other workspaces, to interfere with the service, to reverse-engineer it, or to use it to provide a competing service. We may suspend accounts that breach these terms after notice where practicable.

13. Termination

You may close your account at any time. We may terminate for breach with notice, or at the end of the beta with at least 30 days' notice and the ability to export.

14. Law and disputes

These terms are governed by the laws of Romania. Courts of Cluj-Napoca, Romania have jurisdiction, without prejudice to mandatory consumer protection or venue rules that apply to you. Before any court action, both parties will try to resolve the matter by correspondence for at least 30 days.

15. Changes to these terms

We will post changes here with a new date and notify account holders by e-mail of material changes at least 14 days before they take effect.