Scientific and Medical Communication Services
Pubrica provides scientific and medical communication services for pharmaceutical, biotechnology and medical device companies, researchers, clinicians and professional societies. Each output is governed by a different framework: a journal article by the ICMJE and COPE, a submission document by an ICH guideline or an MDR annex, an accredited education activity by the ACCME Standards or EACCME criteria, and promotional material by the ABPI Code, EFPIA, FDA rules, PAAB or the PMD Act, depending on the market. These frameworks are not interchangeable, and a common error is applying the rules for one output to another. Our medical communications writers prepare each output to the framework that governs it, and this page explains which framework applies to each service.
Journal articleICMJE, COPE, GPP 2022
Submission documentICH, MDR, IVDR, ISO
Accredited educationACCME Standards, EACCME
Promotional materialABPI, EFPIA, FDA, PAAB, TGA
Thought leadershipNo formal code; a house standard applies
Output → audience → market → framework → the relevant service page
- One named governing framework
- Current version confirmed at project start
- No journal codes applied to campaigns
- No promotional codes applied to papers
- Framework set by market, not format
Our Services
Six Scientific and Medical Communication Services
Each service page names the framework that governs its work, so the applicable rules are stated on the page that handles each output.
Service Scope
Scientific Communication Services by Output
Each service page names the framework that governs its work, at its current version.
1RESEARCH AND REGULATORYpapers and submissions
Scientific and academic writingICMJE, COPE and the reporting guideline your design requires. Regulatory writingICH, MDR, IVDR and ISO, with each document written to its own instrument.2EDUCATION AND PROMOTIONclinicians and customers
CME content developmentACCME Standards and EACCME 3.0 criteria. We are not an accredited provider. Marketing communicationABPI 2024, EFPIA, FDA, PAAB, TGA and the PMD Act, by market.3CORPORATE AND QUALITYreports and editorial checking
Thought leadership and editorial designUsually no formal code applies. Editorial and quality supportIndependent editorial checking at a level agreed before the quote.Who We Serve
Organisations We Support with Scientific Communication
We support six types of client, each of whom must communicate one body of evidence to several audiences under a different set of rules for each.
Service Limitations
We do not guarantee journal acceptance, an accreditation decision, a regulatory approval, a review outcome or a commercial result, and each service page states this in its own terms. We are not your medical, legal and regulatory reviewers, accreditor, notified body, qualified person, regulatory strategist or media agency. We do not hold accreditation and cannot accredit content. We do not submit to any authority on your behalf. We do not write promotion for an unapproved use, a claim the evidence does not support, or an authorship line that does not meet the four ICMJE criteria. We do not work on competing products in the same indication concurrently, and where a conflict exists we say so before accepting the work. Our core principle: we do not apply one framework to an output that another framework governs. A journal code does not make a campaign more rigorous, and a promotional code does not govern a paper. We confirm which frameworks apply to each output before work begins.
Compliance and Standards
Global Regulatory and Publication Guideline Landscape
We reviewed these frameworks and confirmed their versions on 22 September 2026. Each service page states the guidance that applies to its own work.
Publication ethics (journal publications only)
The ICMJE Recommendations, updated January 2026, with the four authorship criteria — all four must be met by every author — a new section on artificial intelligence and a new requirement that all authors be able to review the data supporting the results. COPE for publication ethics: text recycling under its position of 20 August 2024, corrections, retractions, authorship disputes, and its September 2025 caution that AI detection tools “should not be relied upon in isolation”. GPP 2022 where the research is company-sponsored, published in the Annals of Internal Medicine on 30 August 2022 and stewarded by ISMPP; GPP3 is superseded and there is no GPP4. CRediT is ANSI/NISO Z39.104-2022, with fourteen roles. These frameworks govern journal papers and do not apply to the other outputs on this page.
Reporting guidelines (one per study design)
CONSORT 2025 for trials and SPIRIT 2025 for protocols, both published in April 2025, both stating that their predecessors should no longer be used. Their extensions, including CONSORT-AI, have not yet been realigned. PRISMA 2020 for systematic reviews, published in 2021 despite its name, with PRISMA-P 2015 for protocols. STROBE (2007) for observational studies, still current. STARD 2015, TRIPOD+AI (2024), ARRIVE 2.0, CHEERS 2022, COREQ, SRQR and CARE. Each guideline is cited with its version, confirmed at project start.
Regulatory instruments (submissions and lifecycle)
ICH E6(R3) for good clinical practice, M11 for protocols, E3 for clinical study reports, M4(R4) for the CTD, E2C(R2) for PBRERs, E2F for DSURs, and E2E for pharmacovigilance planning. These instruments govern regulatory documents only. For devices: MDR Annex XIV and IVDR Annex XIII with the MDCG series, ISO 14155:2026, ISO 14971:2019 and ISO 20417:2026, two of which changed in March 2026. ICH is the International Council for Harmonisation — renamed from “Conference” on 23 October 2015.
Continuing education (two different structures)
In the United States, the ACCME Standards for Integrity and Independence — five Standards, effective 1 January 2022, replacing the Standards for Commercial Support — over eight named accreditation criteria. ACCME accredits organisations; activities are designated for credit. The AMA owns the AMA PRA Category 1 Credit designation and is not an accreditor. In Europe the EACCME, run by the UEMS, accredits individual activities under its 3.0 criteria in force since 2023 — a genuinely different structure. In the UK the GMC mandates no number of CPD points at all.
Promotional codes (by market)
United Kingdom: the ABPI Code, 2024 edition, administered by the PMCPA, over the Human Medicines Regulations 2012. European Union: the EFPIA Code and national association codes, over Directive 2001/83/EC. United States: FDA rules enforced by OPDP under the Federal Food, Drug and Cosmetic Act with 21 CFR parts 200, 201 and 202, plus the PhRMA Code and the AdvaMed Code of Ethics; the clear, conspicuous and neutral final rule for DTC broadcast had a compliance date of 20 November 2024. Canada: the PAAB Code with Ad Standards. Australia: the Therapeutic Goods Advertising Code under the Therapeutic Goods Act 1989. Advertising a prescription medicine to the general public is prohibited in almost every market other than the United States.
Japan (current statute name)
The PMD Act — the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. This is what the Pharmaceutical Affairs Law was renamed in 2014, and many sources still use the old name. Alongside it sit the MHLW guidelines on sales information provision activities for prescription drugs and the JPMA code. Regulatory submissions go to the PMDA, which accepts eCTD v4.0; we could not verify a mandatory transition deadline from the PMDA’s own publications.
Responsible Use of AI
Responsible Use of AI in Scientific Communication
Promotional material is regulated on the substantiation behind each claim. A generated sentence that overstates a benefit is a compliance finding, so we restrict how AI tools are used.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Scientific Communication Process Works
One body of evidence usually becomes five or six outputs, each governed by different rules. If the sequence is decided afterwards, a finding published in a white paper can prevent journal publication.
Evidence Review and Output Mapping
We review all planned outputs in one discussion: the paper, the submission, the education, the promotional material, the patient version and the corporate piece. Many programmes plan these separately, in different teams and on different timelines, and discover conflicts at the end. Listing them together takes about an hour and prevents most of these conflicts.
Governing Framework for Each Output
We identify the ICMJE and COPE for the paper, the ICH instrument or MDR annex for the submission, the ACCME Standards or EACCME criteria for the education, the market’s promotional code for commercial material and, for the corporate piece, usually no formal code. Each framework is confirmed at its current version rather than carried over from the last project. Two of the standards this work depends on changed in March 2026, and two guidelines changed in April 2025.
Output Sequencing Before Drafting
We decide which output goes first and what each one rules out for the others. Publishing a finding in a white paper can put the journal submission at risk, because journals differ on prior publication. Promotional material cannot precede the labelling it describes, and accredited education cannot be built around a product. The sequence is a set of constraints rather than a calendar, and it costs nothing to set correctly at the start.
Authorship, Disclosure and Funding Agreement
We agree who is an author under the four ICMJE criteria, who is acknowledged, what the sponsor’s role was, who funded the writing and how AI use will be declared. These decisions are settled across the whole programme rather than renegotiated per output, because inconsistent disclosures between a paper and a report are easily found by critics and rarely checked internally.
Specialist Writing Within Your Review Process
Regulatory, publications, education and promotional writing are separate specialisms, so each output is written by a specialist writer in that discipline. Each output is written to your templates and enters your review workflow: medical, legal and regulatory review for commercial material, your planning committee for education and your authors for the paper.
Cross-Output Consistency Review
We check that each figure is stated the same way wherever it appears. A number given to one precision in a paper and another in a brochure is a discrepancy, a promotional claim the submission does not support is a regulatory problem, and a disclosure that differs between outputs is a credibility problem. Most problems in a communications programme arise from two documents disagreeing rather than from one being wrong.
Request a Free Framework Map for Your Planned Outputs
Within two business days and at no cost, we map every output you plan, the framework that governs each at its current version, the sequence constraints between them and any points where one output would rule out another. You receive a one-page framework map.
The fixed dates determine the sequence, and they are often the last item clients mention. A congress abstract deadline, a filing date and a launch each constrain when a finding can appear elsewhere, and conflicts between them can almost always be identified in advance.
Framework Router
Identify the Governing Framework for Your Output
Select the type of output, its audience and its market, and the router names the framework that applies, its current version and the service page that handles it. Where no formal code governs the output, as is the case for most corporate content, the router says so.
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The body of rules that applies to your output, at its current version, and where we handle it.
Runs in your browser; no data is sentHow the router works. Each output is matched to the framework that governs it, drawing on the Prescription Drug Marketing Act and the Federal Food, Drug and Cosmetic Act, Directive 2001/83/EC, Health Canada and the PAAB Code, the TGA and the Therapeutic Goods Act 1989, the PhRMA Code and the AdvaMed Code of Ethics where they apply. Each service page names its own framework. For example, thought leadership and marketing communication are governed by advertising and promotional rules rather than by COPE and the ICMJE, which are journal publication ethics bodies. Executive reports, investor white papers, website copy and campaign material are assessed against the codes that apply to them.
Sources. ICMJE Recommendations, PDF dated January 2026 (icmje.org’s HTML pages still showed the January 2024 text when we checked, so we cite the PDF). GPP 2022 via ismpp.org. CRediT: ANSI/NISO Z39.104-2022. ABPI Code current edition confirmed on the PMCPA’s own site on 22 September 2026; EFPIA scope on efpia.eu the same day. FDA statutory basis from the OPDP regulatory information page. ACCME Standards and criteria, and EACCME 3.0 criteria, from accme.org and uems.eu. Points to check in any compliance statement. Superlatives such as “Best” in a page title are unsupported and create a comparative-advertising risk in the regulated markets this work addresses. Japan’s Pharmaceutical Affairs Law should not be listed as current, as it was renamed the PMD Act in 2014. Journal bodies should not be named for work that no journal body governs.
Our Experts
Your Scientific Communication Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field.
Writes the content against the brief and the applicable code of practice, with every claim traceable to its reference.
Reviews the content for scientific accuracy, fair balance and compliance with the applicable code before it reaches your internal review.
Manages the timeline, keeps you informed at each stage and coordinates the team so that questions are answered and deadlines are met.
Sample Work
Sample Evidence Communication Plan: One Trial, Six Outputs
This sample shows the plan we build at stage two, which coordinates the programme so that its outputs do not contradict one another. Use the tabs to view each part, then open the full plan.
Evidence communication plan
One phase III trial · 6 outputs · 3 markets
Outputs · sequence · frameworks · boundaries
7 outputs found, 6 kept4 teams, 1 plan
- An unmapped constraint
- The congress abstract deadline fell eleven weeks before the planned journal submission. Several journals treat a published abstract differently from a full prior publication, and the policy of each candidate journal was checked before the abstract was submitted rather than afterwards.
- The white paper
- The white paper was moved to after the paper’s acceptance, because it would have published the primary endpoint first on a corporate site, which several target journals would have treated as prior publication.
- Promotional material
- Promotional material cannot precede the labelling it describes. It was drafted against the proposed labelling, held and finalised only against the approved text, with every asset recorded against the labelling version it was built on.
- The education module
- The module was built around the clinical question rather than the product, as the ACCME Standards require. It therefore did not depend on the launch date and moved earlier.
- The lay summary
- Under EU CTR Article 37(4), the lay summary is due within twelve months of the end of the trial in all member states concerned, or six months where paediatric participants are included. This legal deadline was not on any team’s plan.
- Outcome of the sequencing
- The sequencing prevented one prior-publication problem and one asset built on superseded labelling, and identified a statutory deadline that had not been scheduled.
- Clinical study report
- ICH E3, with E9 and the E9(R1) estimands addendum for the analysis. No journal body applies.
- Primary publication
- ICMJE for authorship (four criteria, all to be met), COPE for publication ethics, CONSORT 2025 for the reporting, and GPP 2022 because the research is company-sponsored. CRediT is used for contributions.
- Congress abstract and poster
- The congress’s own rules, plus CONSORT for Abstracts, which is separate from the parent statement and increasingly used in screening.
- Education module
- ACCME Standards for Integrity and Independence (five Standards), with the provider controlling every content decision. Neither the ICMJE nor the promotional codes apply.
- Promotional material
- The ABPI Code 2024, EFPIA with the national code, and FDA rules enforced by OPDP, by market, with three market versions rather than one asset with localised disclaimers.
- Lay summary
- EU CTR 536/2014 Article 37(4) and Annex V, written to the Commission’s Good Lay Summary Practice and assessed against a reading level.
3 boundary findingsAll issues resolved before drafting began
Redacted extract · product, indication, client and every figure changedCommunication plan, as delivered
One trial, six outputs, four teams and one plan. Use the tabs to view each part.
The Outputs tab shows why the planning exercise is needed. A seventh output, a corporate white paper quoting the primary endpoint, had been commissioned by a team that had not been consulted and would have published the finding before the journal saw it. It was identified in a one-hour discussion of what the evidence would be used for.
The Boundaries tab shows where each framework sets limits. The education module could not be built around the product, the promotional claim could not exceed the submission and authorship could not be decided by seniority. Each rule comes from a different framework, and none would be identified by applying one framework to every output.
If you request sample work, we will build a plan around an evidence set like yours, with the same outputs, markets and fixed dates.
Scientific medical communication · sample plan
Evidence communication plan — one phase III trial, six outputs, three markets
An illustrative, anonymised plan showing the structure, the categories of finding and the format we deliver. Ask us and we will build one around an evidence set like yours.
1Every output the evidence has to become
Produced in a single one-hour discussion with the four teams responsible for its parts. None had seen the others’ timelines, which is common and is why this document is needed.
| Output | Owner | What was found |
|---|---|---|
| Clinical study report | Clinical operations | On track. This is the anchor document, and every figure elsewhere must agree with it. |
| Primary publication | Medical affairs | A target journal shortlist existed, but prior-publication policies had not been checked. |
| Congress abstract and poster | Medical affairs | The deadline was eleven weeks before the planned journal submission, and its implications for each candidate journal had not been checked. |
| Accredited education module | Medical education | The brief asked for the module to be built around the product, which the ACCME Standards do not permit. |
| Promotional material, three markets | Commercial | Planned as one asset with localised disclaimers and drafted against proposed rather than approved labelling. |
| Corporate white paper | Communications | An output no one had mentioned. It was commissioned separately, quoted the primary endpoint and was scheduled before the journal submission, which would have put the paper at risk. |
| Lay summary of results | Not assigned | Required under EU CTR Article 37(4) within twelve months of the end of the trial, or six months where paediatric participants are included. This statutory obligation was not on any team’s plan. |
The one-hour discussion identified an output that would have damaged another and a legal deadline with no owner. These issues arise when six outputs from one body of evidence are planned in four places, which is common practice.
2The framework governing each output
| Output | What governs it | What does not apply |
|---|---|---|
| Clinical study report | ICH E3 for structure, with E9 and the E9(R1) estimands addendum for the analysis, and patient narratives written from source data under E3 §12.3. | No journal body or promotional code applies. |
| Primary publication | ICMJE for authorship (four criteria, met by every author); COPE for publication ethics; CONSORT 2025 for reporting, which supersedes CONSORT 2010; GPP 2022 because the research is company-sponsored; CRediT for contributions. | The promotional codes do not apply unless a reprint is used as a sales aid, in which case the use, not the format, decides. |
| Congress abstract | The congress’s own rules plus CONSORT for Abstracts, a separate document from the parent statement that is increasingly used in screening. | It does not replace the full reporting guideline. |
| Education module | ACCME Standards for Integrity and Independence, five Standards effective 1 January 2022, with the accredited provider controlling every content decision. In Europe, EACCME 3.0 criteria, under which the activity itself is accredited, a different structure. | Neither the ICMJE nor the promotional codes apply. The AMA is not an accreditor; it owns the credit designation. |
| Promotional material | ABPI Code 2024 with the PMCPA in the UK; EFPIA and the national code in the EU under Directive 2001/83/EC; FDA rules enforced by OPDP in the US under the FD&C Act with 21 CFR 200, 201 and 202. | COPE and the ICMJE do not apply. They are often listed for promotional material but govern none of it. |
| Lay summary | EU CTR 536/2014, Article 37(4) and Annex V, to the Commission’s Good Lay Summary Practice, measured against a reading level. | It is not a marketing document or patient-facing promotion, which would be prohibited in most markets. |
| Corporate white paper | No formal code, unless it names the product, in which case the promotional codes above apply regardless of what it is called. Advertising-disclosure rules apply where a placement is paid. | COPE and the ICMJE do not apply, because a white paper is not a journal paper. |
3Output sequence and constraints
| Constraint | What it forced |
|---|---|
| Prior publication | The white paper was moved to after journal acceptance. Journals differ on what counts as prior publication, and each candidate journal’s policy was read before the abstract was submitted. |
| The congress deadline | Eleven weeks ahead of the planned submission. Abstract policies were checked for each journal, and the abstract was written so as not to prevent publication of the paper. |
| Labelling | Promotional material cannot precede the labelling it describes. It was drafted against proposed labelling, held and finalised against approved text, and every asset was recorded against its labelling version, so a later label change takes an hour rather than a fortnight. |
| Product independence | The education module was rebuilt around the clinical question rather than the product, as the Standards require. It then had no dependency on the launch date and moved earlier in the programme. |
| The statutory deadline | The lay summary is due within twelve months of the end of the trial, or six months with paediatric participants. It was scheduled, assigned an owner and scoped. |
| One asset or three | Three market versions of the promotional material were prepared rather than one localised asset. This costs more at quote but less by the second review cycle, and it is the only approach that is compliant in all three markets. |
4Boundaries set by each framework
| Request | Answer, and why |
|---|---|
| Build the education module around the product | No. Under the ACCME Standards, the accredited provider must control every decision on planning, faculty, delivery and evaluation without influence from owners or employees of ineligible companies, and accredited education must be free of marketing. The module was rebuilt around the clinical question, which improved it and removed its dependency on the commercial timeline. |
| Use the promotional claim as drafted | Narrowed. It described a benefit that the submission stated more conservatively. Assessors and code bodies both look for two documents disagreeing about the same product. The claim was reconciled to the narrowest defensible statement and used everywhere. |
| Keep the author list as proposed | Changed. Two proposed authors did not meet all four ICMJE criteria, and one person who did was not listed. This was resolved before submission, which avoids later correspondence with the editor. |
| Produce a patient-facing piece naming the product | Removed for two of three markets. Promoting a prescription medicine to the general public is prohibited in almost every market other than the United States. Replaced with the lay summary, which is a different document with a different purpose and a legal deadline. |
| Use a reprint of the paper as a sales aid | Permitted, with conditions. The paper is not promotional material, but a reprint used as a sales aid is. The use, not the format, decides, and the accompanying material the market’s code requires applies. |
| Round the primary endpoint for the brochure | No. The same figure at different precisions in two documents is a discrepancy rather than a formatting choice, so one figure at one precision is used everywhere. |
5One disclosure position across all outputs
| Element | Settled once, applied everywhere |
|---|---|
| Authorship | Assessed against the four ICMJE criteria for the paper, with contributions recorded in CRediT. Authorship is not based on seniority and is not renegotiated per output. |
| The sponsor’s role | Described the same way in the paper, the white paper and the education disclosures. Under GPP 2022 the sponsor’s role in company-sponsored research is disclosed rather than implied. |
| Writing assistance | Our involvement acknowledged, with its funding source — which Springer Nature and BMC require explicitly, and which the ICMJE addresses by stating that writing assistance does not confer authorship. |
| AI use | Declared in the form each publisher requires, which differs among the four largest publishers, and declared to the education provider where AI was used in module content. |
| Commercial support | For the education module, under Standard 4: a written agreement with the provider, all funds to the provider, the supporter named to learners before they engage, and no content or faculty involvement. |
| Consistency check | All disclosures were read side by side before anything was published. A disclosure that differs between two outputs is easily found by critics and rarely checked internally. |
Limitations of the plan: A plan does not ensure that a journal accepts the paper, an accreditor commends the programme, an agency approves the submission or a code body dismisses a complaint. It prevents outputs from the same evidence contradicting each other, prevents one output ruling out another, and assigns an owner to statutory deadlines. These are the three failures we see most often, and none is caused by a lack of expertise in the teams involved.
Benefits
Benefits and Limits of Integrated Communication Planning
No supplier controls the decisions of a journal, an accreditor, an agency or a code body. Planning outputs together ensures that they do not contradict each other and that one does not compromise another.
Packages
Scientific Communication Packages
These four packages are priced and structured for work that spans more than one framework. If you need a single output, the individual service pages price it separately, which is usually less expensive.
Communication Plan
For any programme in which one body of evidence becomes more than two outputs
From $1,800up to 8 outputs · 3 markets · plan only
Delivery 10 business days
- ✓Every output listed, including those commissioned by other teams
- ✓The governing framework named per output, at its current version
- ✓Sequence set as constraints, showing what each output rules out
- ✓Authorship, disclosure and funding settled once across the set
- ✓Statutory deadlines identified and given an owner
Credited in full against writing commissioned within 90 days.
View a sample Select MapThree Outputs from One Evidence Base
A paper, a congress presentation and one commercial or education output from the same study
From $6,4003 outputs · 1 market for commercial · 3 revision rounds
Delivery 25–35 business days
- ✓Everything in Map, plus the outputs themselves
- ✓A specialist writer for each output
- ✓Each written to its own framework and into your own review process
- ✓Cross-checked as a set, with figures, claims and disclosures reconciled
- ✓One disclosure position running through all three
You choose the three outputs. Most sets combine a paper, a congress piece and either an education or a commercial output.
View a sample Select SetFull Communication Programme
For a launch or major readout with outputs across research, regulatory, education and commercial
From $18,0005–7 outputs · up to 3 markets · unlimited rounds within the agreed scope
Delivery Delivered to your fixed dates
- ✓Everything in Set, across the whole programme
- ✓Market versions written to each code rather than localised from one
- ✓Substantiation file for the commercial material; evidence file for the education
- ✓A labelling version register across every asset
- ✓Statutory obligations delivered as well as identified
Regulatory submission documents are quoted on our regulatory writing page and priced separately.
View a sample Select ProgrammeFramework Review of Existing Material
For organisations that need to check whether existing material was built to the correct framework
From $2,400up to 40 assets · framework and version check
Delivery 15 business days
- ✓Every asset matched to the framework that actually governs it
- ✓Guideline and code versions checked against what is current
- ✓Claims and figures reconciled across the estate
- ✓Disclosures read side by side for inconsistency
- ✓A prioritised list of what to fix now and what to fix at the next revision
The review shows what to correct now and what to correct at the next revision.
View a sample Select AuditDeliverables
The output map
Included for every outputwith its framework
Including those commissioned by other teams
A one-page list of every output the evidence will become, the framework governing each at its current version and its owner. It identifies outputs that do not appear in any single team’s plan.
Deliverables
The constraint list
Not a calendara set of constraints
What each output forecloses for the others
Prior publication, labelling dependency, product independence for accredited education, and statutory deadlines with dates. These constraints are simple to set at the start and costly to discover at the end.
Deliverables
The disclosure position
Settled onceapplied everywhere
Authorship, sponsor role, funding, AI
One position across the whole programme rather than renegotiated per output. Disclosures that differ between a paper and a report are easily found by critics, because the documents are rarely read side by side internally.
Available alongside any package: individual outputs from the service pages, which is usually less expensive if you need only one; regulatory submission documents, quoted separately; additional markets as separate deliverables rather than localisation passes; translation with terminology checked against each market’s code; a standing arrangement across a portfolio; and expedited delivery where capacity allows, quoted on capacity rather than urgency.
Quality Assurance
Our Service Commitments and Limitations
We set out below what we commit to and what lies outside our control.
Our revision commitment
Revision Support Within the Agreed Scope
We revise each output until it meets the framework it is written to, with no limit on rounds within the agreed scope, and the writer remains available through your review, submission or journal revision cycle.
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One named framework per output
Confirmed at its current version at the start of the project. We never apply a journal code to a campaign or a promotional code to a paper.
02
Outputs reviewed as a set
Figures, claims and disclosures are reconciled across every output, because most problems arise from two documents disagreeing rather than one being wrong.
03
Specialist writers for each discipline
Regulatory, publications, education and promotional writing are separate specialisms, and each output is written by a specialist in its discipline.
04
Corrections at Our Cost
If a framework is misapplied, a version is out of date or a figure is inconsistent across outputs because of our error, we correct it at no cost within the agreed scope and inform you first.
Service limitations. We do not guarantee journal acceptance, accreditation or commendation, regulatory approval, a review outcome, a code decision or a commercial result, and each service page states its own limitations. We are not your medical, legal and regulatory reviewers, accreditor, notified body, qualified person, regulatory strategist, media agency or lawyers. We hold no accreditation and cannot accredit content, and we do not submit to any authority on your behalf. We will not write promotion for an unapproved use, a claim the evidence does not support, an authorship line that fails the four ICMJE criteria, or accredited education built around a product. We do not work on competing products in the same indication concurrently, and where a conflict exists we say so before accepting the work. Our core commitment: we name only the frameworks that govern each output, and we confirm which of them apply before work begins.
Free framework map
Tell us every output the evidence will become, including pieces owned by other teams, and we will send a one-page map within two business days showing the framework governing each output at its current version, the sequence constraints between them and any conflicts between outputs. There is no cost or obligation, and it requires about one hour of discussion.
Review of existing material
Send a set of existing material and we will identify the framework each piece was built to, whether that framework governs it and whether the versions cited are current. Issues we check for include a journal ethics body cited as the compliance standard for promotional material, a regulator dissolved in 2020, a statute renamed in 2014, a superseded publication guideline listed as current and an unsupported superlative in a page title.
Versions confirmed at project start
Every guideline, code, standard and statute is confirmed as current at project start rather than carried forward from the last project. In the last two years CONSORT and SPIRIT were both replaced, the ICMJE Recommendations were updated, two device ISO standards were replaced in a single month, ICH E6 moved to R3 and E2D to R1, and the ACCME Standards replaced the Standards for Commercial Support. A carried-forward template would miss each of these changes, which is why the check is a fixed step in our process.
Confidentiality and Conflicts of Interest
A non-disclosure agreement is signed before any material is shared, and writers and project staff are bound by internal confidentiality agreements. Unpublished data, submission drafts, labelling texts, agency correspondence and launch plans are held under the UK GDPR on access-controlled systems within a quality management system certified to ISO 9001:2015 (certificate H3CR9TCU20251212INDQM10N). They are kept only as long as the project requires, never used for training and never shared outside your project team. We do not work on competing products in the same indication concurrently, and we tell you if a conflict exists.
Client Stories
Client Feedback on Scientific Communication Programmes
These testimonials are paraphrased from client feedback. None claims an acceptance, an approval or a commercial result.
“A white paper from another team was going to publish our primary endpoint before the journal saw it. One conversation found it.”
“Nobody owned the lay summary. It is a legal deadline and it was on no team’s plan at all.”
“Our agency had built the campaign to a publication ethics code. They are not the same rules and nobody had noticed.”
FAQs
Frequently Asked Questions About Scientific Medical Communication
If you are not sure which framework governs your output, use the router above, or ask an expert. No quote is required.
Scientific and medical communication covers everything an organisation publishes about medicine. It is not one discipline with one set of rules. A journal article is governed by the ICMJE and COPE, a submission document by an ICH guideline or an MDR annex, an accredited education activity by the ACCME Standards or EACCME criteria, and promotional material by the ABPI Code, EFPIA, FDA rules, PAAB, the Therapeutic Goods Advertising Code or the PMD Act, depending on the market. A corporate white paper usually has no formal governing code. This page maps outputs to their frameworks, and each of the six services handles one part: scientific and academic writing, regulatory writing, CME content development, marketing communication, thought leadership and editorial design and editorial and quality support.
No. They govern journal publication: authorship of research papers, editorial decisions, corrections, retractions and publication ethics. They do not apply to a brochure, a web page, a sales aid, a campaign or an executive report, and citing them for commercial material does not raise the standard. Promotional material is governed by the code of each market it reaches. One exception is worth noting: a journal article is not promotional material, but a reprint used as a sales aid is. The use, not the format, decides, and the accompanying material the market’s code requires applies. Similarly, GPP 2022 applies to publications from company-sponsored research, where publication ethics and commercial interests meet.
One supplier can coordinate all of it, but one writer cannot write every output to the required standard. A regulatory writer experienced in clinical study reports, a publications writer experienced in journal review, an education writer who understands accreditation requirements and a promotional writer who knows the market’s code are different specialists. The coordination layer benefits from a single supplier: the output map, the sequence constraints, the single disclosure position and the cross-set check that keeps figures consistent. This page covers that coordination, and the specialist writing is priced on the individual service pages.
Sequence is a set of constraints rather than a calendar, and four constraints recur. Prior publication: journals differ on what counts as prior publication, so publishing a finding in a white paper, a press release or on a corporate site can put the paper at risk. Check each candidate journal’s policy beforehand. Labelling: promotional material cannot precede the labelling it describes, so it is drafted against proposed text, held, and finalised against approved text with the version recorded. Product independence: accredited education cannot be built around a product, so it usually has no dependency on the commercial timeline and can move earlier. Statutory deadlines: a lay summary of trial results under EU CTR Article 37(4) is due within twelve months of the end of the trial, or six months with paediatric participants. This legal obligation is often missing from every team’s plan because no team owns it.
We check versions at the start of each project rather than carrying a template forward, and we state on the page where we could not verify something. In the last two years, CONSORT 2025 and SPIRIT 2025 replaced their predecessors in April 2025, both stating that the old versions should no longer be used. The ICMJE Recommendations were updated in January 2026; icmje.org’s HTML pages still showed the 2024 text when we checked, so we cite the PDF. ISO 14155 and ISO 20417 were both replaced in March 2026. ICH E6 moved to R3 and E2D to R1. The ACCME Standards for Integrity and Independence replaced the Standards for Commercial Support with effect from 1 January 2022. The ABPI Code is now in its 2024 edition. A carried-forward template would miss each of these changes, which is why version checking is a fixed step in our process.
A non-disclosure agreement is signed before any material is shared, and writers and project staff are bound by internal confidentiality agreements. Unpublished data, submission drafts, labelling texts, agency correspondence and launch plans are held under the UK GDPR on access-controlled systems within a quality management system certified to ISO 9001:2015, certificate H3CR9TCU20251212INDQM10N, kept only as long as the project requires and never used for training. Two further measures apply to programmes of this kind. Access is granted per output, not per client: the writer on the promotional material does not need, and does not receive, the submission dossier. Conflicts of interest: we do not work on competing products in the same indication concurrently, and where a potential conflict exists we tell you before accepting the work.
Every framework on this page is named with its version and the date we checked it. Where we could not verify something, the page says so rather than filling the gap. Every price is shown with its scope limits. Every sample is a complete deliverable published on the page, including findings that went against the client. Where a claim commonly made in this field is incorrect, the page says so and explains how to check it.
Insights
Further Reading on Publication and Funder Requirements
Three articles on the funder and publication rules that determine where evidence can appear.
Request a Free Communication Framework Map
We provide a one-page map within two business days, showing the framework governing each output at its current version, the sequence constraints between them and any conflicts between outputs. It requires about one hour of discussion.
Guides and articles in this section
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- Advisory Board Materials and Facilitation
- Congress and Symposium Content
- KOL and DOL Mapping and Insight Reporting
- Medical Affairs Strategy and Tactical Planning
- Medical Information and Standard Response Documents
- MSL and Field Medical Materials and Training
- Publication Extenders and Modular Content
- Publication Planning and Strategy | GPP 2022
- Publication SOPs and Steering Committee Support
- Scientific Platform, Narrative and Lexicon
- Technology-Enabled Medical and Scientific Communication