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Standards and Certification at Pubrica

Pubrica works to the publication, regulatory and accessibility standards your work will be judged against, and holds ISO 9001:2015 for the way the work itself is run.

We follow COPE and the ICMJE Recommendations for authorship and research integrity, GPP 2022 for company-funded research, and the EQUATOR reporting guideline your study design requires. We apply ICH for clinical documents, EU MDR and IVDR for devices and diagnostics, CDISC for study data, and WCAG 2.2, Section 508 and EN 301 549 for digitally published content. Each standard is described below with what it requires of us. The ISO certificate is the only item examined by an external auditor, and a copy is available on request; the others are standards Pubrica applies to your work. The bodies whose guidance we follow are listed on our partnerships page.

Ask for the certificate About Pubrica
The standards Pubrica works to, checked in turn A register of six standards — CONSORT 2025, ICMJE, GPP 2022, ICH E6(R3), EU MDR 2017/745 and ISO 9001:2015 — each checked against the edition in force. STANDARDS IN FORCE checked CONSORT 2025 randomised trials ICMJE authorship and disclosure GPP 2022 company-funded research ICH E6(R3) good clinical practice EU MDR 2017/745 devices and diagnostics ISO 9001:2015 quality management, certified Each one named at the edition in force
Six of the standards Pubrica works to. Each is named at the edition in force, and the sections below set out what each requires.
CertifiedOne: ISO 9001:2015, third-party audited
ISO 9001:2015cert. H3CR9TCU20251212INDQM10N
AlignedCOPE, ICMJE, GPP 2022, EQUATOR
AppliedICH, MDR, IVDR, CDISC, WCAG 2.2
LabelledEach item marked by type
2009Supporting authors since

Compliance and Standards

Certificates, Memberships and Standards: The Difference

These are three different things, and procurement and compliance teams usually ask about the difference first. This section explains which category each item on this page belongs to.

A certificate: externally audited An external auditor has assessed how we run our work and issued a numbered certificate. We hold one: ISO 9001:2015, cert. H3CR9TCU20251212INDQM10N. A copy is available on request so that you can verify it. This is the only category in which an organisation outside Pubrica has examined our work.
A membership: joining a professional body A member has joined a body and accepted its code of conduct, which commits the member to that code and gives clients an independent route for complaints. A membership is not an audit of anyone’s work. Pubrica holds no memberships and claims none. We follow the guidance published by five publishing and editorial bodies, which is set out on the partnerships page.
A standard: applied to your work A standard sets out what the finished document must contain, and it can be applied without belonging to any body. Most reporting guidelines work this way. Because a standard is easy to claim and difficult for clients to verify, we label it separately from the certificate.

Of ICMJE, COPE, ISO and GDPR, ISO is a certificate, ICMJE and COPE are codes of conduct and GDPR is a law, so this page labels each one by type rather than showing them in a single row.

Publication and ethics bodies

Publication Ethics and Reporting Standards We Follow

These standards determine what can be claimed about research, who qualifies as an author and what must be disclosed.

COPE — Committee on Publication Ethics COPE covers authorship disputes, duplicate publication, undeclared conflicts of interest, altered images, and the handling of corrections and retractions. When an integrity question arises in your project, we follow the COPE flowcharts, which are the same ones the journal will use.
ICMJE Recommendations The ICMJE Recommendations set four criteria for authorship, and each author must meet all four. Contributors who do not meet all four are named in the acknowledgements; they are never omitted and never given authorship as a courtesy. The Recommendations also require disclosure of AI use in preparing the manuscript, and AI cannot be listed as an author.
GPP 2022 — Good Publication Practice The 2022 edition, which replaced GPP3, applies to company-funded research. It recognises professional writing support as legitimate, provided the writer’s contribution is disclosed.
EQUATOR Network EQUATOR hosts the reporting guidelines, including CONSORT 2025 for trials, PRISMA 2020 for systematic reviews, STROBE, ARRIVE 2.0, STARD, TRIPOD+AI, CARE and COREQ. Your study design determines which one applies, and we use the version in force on the day we write.

Regulatory and technical standards

Regulatory and Technical Standards for Clinical, Device and Digital Documents

These apply when the reader is a regulator, a notified body or a procurement team rather than a journal editor.

ICH efficacy guidelines E6(R3) for good clinical practice, E3 for the clinical study report, E2C(R2) for periodic safety reports, and M11 for the protocol template, which reached Step 4 in November 2025.
MDR and IVDR Regulations (EU) 2017/745 and 2017/746 for medical devices and in-vitro diagnostics, together with the MDCG guidance your notified body assesses against: 2019-9 rev 1, 2020-5, 2020-6, 2020-7, 2020-8 and 2020-13.
CDISC CDASH when the data is collected, SDTM to tabulate it, ADaM for the analysis datasets and Define-XML for the metadata — in the versions the FDA Data Standards Catalog asks for on your study.
WCAG 2.2, Section 508 and EN 301 549 For digitally published content. We document conformance in a written report rather than simply claiming it, because buyers now request the report.

Compliance

Frequently Asked Questions About Compliance

If yours is not here, ask an expert — no quote required.

Yes. Ask and we will send you a copy. The number is cert. H3CR9TCU20251212INDQM10N, and it is printed on every service page on this site so that you can check it without asking us first.

It is the only credential on this page that a third party has audited, and it should be distinguished from the others.

Logos placed side by side make an audited certificate, a code of conduct, a reporting guideline and a payment badge look equivalent, when they are not.

So this page labels each item by type, and the badges in the site footer are grouped the same way: trust and security, secure payments, and the publication-ethics guidelines we follow. ISO 9001:2015 is the only one an external auditor has examined.

No, because no such accreditation exists for writing services. A supplier claiming one is describing something else.

What does exist is a quality certificate for how the work is run, which we hold, and the regulatory standards the documents themselves have to satisfy, which are listed above.

We work with journals, societies and publishers as a supplier of editorial services, and those are commercial arrangements rather than endorsements of us. They are set out on the partnerships page, along with the partner programme for organisations that send work regularly.

We do not own any journals, which is why our journal recommendations can be independent: nothing is suggested to you because we publish it.

Request the ISO Certificate or Ask About the Standards for Your Project

We respond to both requests directly, and the second usually tells you more about how your work will be handled.

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