Compliance Policy

Stated first, because everything else depends on it:

• SterileAtlas is not a GxP system. It is not validated, not qualified, and not offered as a computerised system supporting a regulated process under EU GMP Annex 11, GAMP 5, or an equivalent framework.
• It makes no 21 CFR Part 11 claim. Nothing recorded here is offered as an electronic record or electronic signature meeting Part 11, and it must not be used as the record of a regulated activity.
• It is not a regulatory submission channel, a complaint intake, a deviation system, a training record, or a document management system of record.
• It is not an auditor, certifier, or regulator. Listings, badges, and scores are not audits, certifications, or approvals — see the Disclosure Policy.

What the Platform does provide, and describes honestly on the Trust & security page, is access control, an append-only audit trail of platform actions, and a record of who did what and when inside the product.

Finding a supplier here does not discharge the duty to qualify one. Whatever your framework requires — supplier qualification and ongoing oversight under ICH Q10, the control of outsourced activities under EU GMP Chapter 7, written agreements defining responsibilities, audits, and the assessment obligations in 21 CFR Parts 210/211 or your local equivalent — remains yours in full.

Use a listing as an input to that process: a way to find candidates, compare stated capabilities, and open a conversation. Do not use it as evidence in the process.

SterileAtlas is not a pharmacovigilance channel. We do not monitor content for adverse events, product quality complaints, or safety signals, and posting one here does not report it to anybody who can act on it.

If you become aware of an adverse event, a suspected product defect, or a safety issue, report it through your own pharmacovigilance and quality systems and to the relevant authority, within your own timelines. Do so whether or not it was mentioned on this platform. Do not post case narratives or patient details here in any circumstance.

Do not upload, message, or otherwise place patient-identifiable data, clinical records, or protected health information on the Platform. SterileAtlas is not a covered entity or a business associate under HIPAA, has not signed a business associate agreement with you, and its features are not designed to hold that class of data. Clinical content shared here should be de-identified and aggregate.

Zentrum24 LLC operates from the United States and applies US law to its own dealings, alongside the law of the places it serves.

• You may not use the Platform if you are a restricted party under OFAC or an equivalent list, or if you are acting for one.
• You may not use it to arrange a transaction that sanctions or embargoes prohibit, or to conceal one.
• Do not transmit export-controlled technical data (EAR/ITAR or a national equivalent) through listings, messages, rooms, or file uploads. Screening a counterparty and licensing a transfer are your responsibility, not ours.
• We may suspend accounts and refuse service where a sanctions or export obligation requires it.

Zentrum24 LLC prohibits bribery in every form, including facilitation payments, and expects the same of everyone on the Platform. The US Foreign Corrupt Practices Act and the UK Bribery Act reach conduct far beyond their own borders, and a payment routed through a consultant is still a payment.

• No offering, giving, requesting, or accepting anything of value to win business, secure a selection, or influence a decision — including through an intermediary engaged here.
• No kickbacks on an engagement arranged through the Platform, and no undisclosed commission for making an introduction.
• Interactions with healthcare professionals and public officials must follow the transparency and reporting rules that apply to them, including US Open Payments where relevant.
• Declare a conflict of interest to your counterparty when one exists — for example, evaluating a bid from an organisation you have an interest in.

The Platform puts competitors in the same place, sometimes in the same room. That is useful and it is also a risk you must manage.

• Never agree, signal, or hint to a competitor about prices, discounts, capacity limits, territories, customers, or who will bid.
• Do not exchange competitively sensitive information — current or forward pricing, costs, margins, or bid intentions — in messages, rooms, or meetings.
• Do not use an RFx to coordinate a market or to gather a rival’s commercial terms under the cover of a procurement.
• If a conversation moves that way, stop it, leave, and tell your own legal function.

Formulations, processes, and study designs are among the most valuable things anyone on this platform owns. Put an NDA in place before you share them, use invite-only requests where a public one would expose your programme, and share only what a counterparty needs at the stage you are at. Do not post a third party’s confidential information, and do not use what you receive here for anything other than evaluating the engagement it was shared for.

Zentrum24 LLC processes personal data as described in the Privacy Policy, and as a processor for member content under the Data Processing Addendum, which names the subprocessors. Visitors in the EU/EEA and UK have GDPR rights and residents of applicable US states have their own; both routes go to privacy@zentrum24.com. When you upload someone else’s personal data — a colleague as a key contact, a participant in a meeting — you are responsible for having a lawful basis to do so.

Platform actions that matter — claims, ownership changes, moderation, archiving, and deletion decisions — are written to an append-only audit trail with the actor, the time, and the entity. Deletion of a company listing is deliberately not a one-party act: the company asks, a SterileAtlas administrator decides, and the decision record survives the deleted listing so that what happened can still be reconstructed.

Retention periods, and how to obtain your own data, are in the Privacy Policy. Keep your own regulated records in your own validated systems; do not rely on this platform to retain them.

Zentrum24 LLC commits to describing the Platform’s capabilities and its limits accurately, to labelling what is unverified, to keeping commercial relationships out of scoring and ordering, to acting on credible reports of false regulatory claims, and to saying what is not yet true rather than implying it is. Where a control is on the roadmap rather than in place — SOC 2 is the current example — the Trust & security page says so in those words.

Report a compliance concern — a false regulatory claim, a suspected kickback, a sanctions issue, an antitrust conversation, or conduct by SterileAtlas itself — to legal@zentrum24.com. Say what you saw, where, and when. We do not retaliate against anyone who reports in good faith, and we will not disclose your identity beyond those who need it to investigate, unless the law requires it.

Zentrum24 LLC · 1621 Central Ave, Suite 9103, Cheyenne, WY 82001 · governed by the laws of the State of Wyoming, USA.