The Verified Standard™

In this field, a company name can do a lot of unearned work. Words like advanced, premium, proprietary and certified get attached to products without anyone defining them, and a visitor is left to assume something reassuring.

We would rather define our terms. Below are the five things we believe every biologic product should be able to answer, followed by what Verified Biologics actually does about each one.

How to read this page

Each pillar has two parts. The principle is what we believe should be true of any biologic product, anywhere. The our implementation box is what Verified Biologics specifically does — and it stays marked as outstanding until the company has confirmed the detail, rather than being filled with plausible-sounding language.

Source

Know where a product comes from.

Every biologic product begins somewhere — a donor, a tissue, a laboratory, a manufacturing process. Where a product comes from shapes everything that follows: how it should be handled, what it can be used for, and what documentation should travel with it. A product whose origin cannot be described clearly is a product nobody should have to guess about.

Our implementation. Our commitment: a product's source is described in the documentation that accompanies it. Specifics are available to qualified professionals on request.

Verified Biologics to describe the specific controls in place for source — for example the processes, records, systems, monitoring and review steps actually used. Only controls that are genuinely implemented should appear here.

Documentation

Important information should be available — and understandable.

Paperwork is not a formality. It is the record of what something is, where it came from, and how it was handled. We believe that record should be available to the professionals who need it, and written clearly enough that it can actually be read rather than merely filed.

Our implementation. Our commitment: the documentation set for a product is stated before anyone commits to it. The documents for a specific product are available to qualified professionals on request.

Verified Biologics to describe the specific controls in place for documentation — for example the processes, records, systems, monitoring and review steps actually used. Only controls that are genuinely implemented should appear here.

Handling

Biologic materials require appropriate handling and storage.

Biologic material is not shelf-stable inventory. Temperature, timing, containers, and transport conditions matter, and the requirements differ from product to product. Handling a biologic correctly is part of respecting what it is.

Our implementation. Our commitment: handling and storage requirements are supplied with each product. Facility and process specifics are available to qualified professionals on request.

Verified Biologics to describe the specific controls in place for handling — for example the processes, records, systems, monitoring and review steps actually used. Only controls that are genuinely implemented should appear here.

Traceability

Products should be identifiable through appropriate records and lot information.

If a question comes up about a specific unit — next week or next year — someone should be able to answer it. Lot identifiers and records exist so that a product can be traced back through the steps it took to arrive.

Our implementation. Our commitment: products carry lot information so questions can be answered later. Record-keeping specifics are available to qualified professionals on request.

Verified Biologics to describe the specific controls in place for traceability — for example the processes, records, systems, monitoring and review steps actually used. Only controls that are genuinely implemented should appear here.

Transparency

Healthcare professionals deserve clear information about what they are considering.

That includes the parts that are still unknown. We would rather say “researchers are still studying that” than imply certainty that does not exist. Clear information — including clear limits — is what makes a good decision possible.

Our implementation. This page is the practice, not just the promise: where specifics are not published here, we say so — and they are available to qualified professionals on request.

Verified Biologics to describe the specific controls in place for transparency — for example the processes, records, systems, monitoring and review steps actually used. Only controls that are genuinely implemented should appear here.

Why five, and why these five

They answer the questions that actually come up.

Not the questions a certification badge answers. The ones a clinician asks at 4pm when a shipment has arrived and something does not look right.

Where did this come from? — Source.
What am I actually holding, and can I read the paperwork? — Documentation.
Was it kept the way it needed to be kept? — Handling.
If a question comes up next year, can anyone answer it? — Traceability.
Am I being told everything, including the limits? — Transparency.

Controlled cold storage equipment with monitoring displays in a laboratory.

What this is not

The Verified Standard™ is not a regulatory approval.

Please read this carefully

The Verified Standard™ is Verified Biologics' own statement of the principles we hold ourselves to. It is not a government approval, a regulatory clearance, an accreditation, a certification issued by any external body, or a substitute for the regulatory status of any individual product. It does not imply that any product is approved for any medical use, and it does not indicate that any product has been shown to be effective for any condition. Each product's actual regulatory status is stated with that product.

No external accreditations, registrations or certifications are claimed on this page. If that changes, any listing here will name the issuing body and scope — and only after it is verified.

Hold us to it

If we fall short of this, we want to hear about it.

A standard nobody can check is a slogan. If you receive something from us and the source, documentation, handling, traceability or transparency is not what this page describes, contact us directly and we will address it.

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