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Medical affairs materials prepared for MLR review

Medical Affairs Content

Pubrica writes medical affairs content for Medical Affairs departments at pharma and biotech companies, field medical and MSL teams, medical information teams, publications teams and market access teams. Each project delivers a Medical Affairs document (a scientific platform, field medical deck or MI response letter), a reference list formatted to journal/GPP 2022 standards, author and contributor disclosure documentation, an MLR-ready submission package and, where applicable, core claims mapping, prepared in line with Good Publication Practice (GPP 2022). Our medical writers and content strategists work in-house. A named subject specialist manages your project from brief to delivery, and a second, independent reviewer checks the work before it reaches you.

  • Medical Affairs document — included in every engagement
  • Reference list formatted to journal/GPP 2022 standards — included in every engagement
  • Author/contributor disclosure documentation — included in every engagement
  • Produced to named standards, including Good Publication Practice (GPP 2022)
  • A published starting price: $3,200 for the standard scope
What is included What is not included

Medical Affairs documentIncluded

Reference list formatted to journal/GPP 2022 standardsIncluded

Author/contributor disclosure documentationIncluded

MLR-ready submission packageIncluded

Work outside the agreed scopeNot included

Brief → scoping → draft → delivered

Every engagement
  • Medical Affairs document
  • Reference list formatted to journal/GPP 2022 standards
  • Author/contributor disclosure documentation
  • MLR-ready submission package
  • Core claims mapping where applicable
$3,200Published starting price
5–10 business daysFrom brief to final delivery
5 deliverablesListed in full below
ISO 9001:2015Quality management certified · cert. H3CR9TCU20251212INDQM10N

Deliverables

Five Core Medical Affairs Content Deliverables

Every item below is prepared for efficient MLR review, produced in-house by Pubrica’s medical writers and content strategists and checked by a second, independent reviewer before delivery.

Medical Affairs document Medical Affairs document (scientific platform, field medical deck, or MI response letter).
Reference list formatted to journal/GPP 2022 standards Reference list formatted to journal/GPP 2022 standards.
Author/contributor disclosure documentation Author/contributor disclosure documentation.
MLR-ready submission package MLR-ready submission package.
Core claims mapping where applicable Core claims mapping where applicable.

Who We Serve

Five Client Groups We Support with Medical Affairs Content

The organizations below commission this service, and each project is planned around the audience who will use the material.

Medical Affairs departments at pharma/biotech companiesA client group that commissions this service directly.
Field medical/MSL (medical science liaison) teamsA client group that commissions this service directly.
Medical information call-center and response teamsA client group that commissions this service directly.
Publications teamsPreparing congress abstracts and scientific platforms
Market access teamsNeeding non-promotional scientific narratives

Compliance and Standards

Medical Affairs Content Standards and Guidelines

The regulatory codes, guidelines and quality standards that apply to this service.

GPP

Good Publication Practice (GPP 2022)

GPP 2022 provides recommendations for the publication of company-sponsored biomedical research, including disclosure of medical writer involvement and authorship criteria.

ICMJE

ICMJE authorship criteria

The ICMJE criteria define the contributorship rules that Medical Affairs scientific content and publications must follow when crediting authors and writers.

FDA

FDA guidance on unsolicited requests for off-label information

This guidance shapes how medical information response letters are written and distributed so that they remain distinct from promotional material.

MLR

Medical-Legal-Regulatory (MLR) Review

The formal internal sign-off process that all Medical Affairs materials -- scientific platforms, field medical slide decks, medical information letters -- are routed through before use.

ISO9001:2015

Quality management (cert. H3CR9TCU20251212INDQM10N)

Governs how each project is managed, reviewed and documented.

Responsible Use of AI

Our Approach to AI Use in Medical Affairs Content

Generative tools are useful for drafting and iteration. They are not used anywhere the output could be mistaken for verified clinical data or a real patient.

What we use it forLayout variations, colour systems, and first-pass drafts that a human then corrects against the brief and the brand or clinical standards that apply.
What we do not use it forGenerating any image, figure or quote presented as real clinical data, a real patient, or a verified result; and nothing goes out without a named reviewer's sign-off.
What we include in your AI declarationThe tool, the stage it was used at, and the human oversight applied — because MLR/PRC reviewers, funders and regulators increasingly expect this stated rather than assumed.

Why we do not publish AI accuracy figures

Accuracy figures for AI design and content tools are usually reported by the vendors that sell them.

For this reason we do not quote an accuracy figure of our own. We tell you which tool was used on your project, at which stage, and what a named reviewer changed afterwards.

Our Process

Medical Affairs Content Process: Four Steps with Draft Review

Each project moves from brief and scoping to a reviewed first draft, then to revisions and final delivery.

Step one

Submit Your Brief and Reference Material

Send us what the document needs to communicate, who will see it and anything that must or must not appear, together with any existing assets, brand guidelines or source material we should work from.

Step two

Initial Scoping Discussion

We confirm the audience, the applicable standards and, for scoped work, the factors that determine the final price, so the quote is agreed before work begins.

Step three

Concept and First Draft

A subject specialist and the production team build the first version against the brief, reviewed internally for accuracy before it reaches you.

Step four

Revisions and Final Delivery

We incorporate your revisions and deliver the files listed on this page, including the working files, so the material can be updated later without starting again.

Request a Free Scoping Assessment for Your Medical Affairs Content Project

We confirm the cost, timeline and applicable standards before you commit to anything. The assessment is free and is completed within two business days.

What you provide
The briefThe purpose of the material and its intended audience
Reference materialExisting assets, brand or style guidelines, prior approved versions
The audienceClinician, patient, payer, investor or internal team
ConstraintsAnything that must or must not appear, and the standards that apply
The deadlineYour deadline, including any congress or submission window
Approval routeWho approves the work, and whether MLR/PRC review is part of the process

Our Experts

Your Medical Affairs Content Team

The same named team of specialists stays with your project from scoping to delivery.

Subject expertSubject matter expert matched to your topic

Determines which claims the evidence supports. The subject expert is matched to your topic and tells you clearly when the brief asks for something the evidence does not support.

OwnsScope, judgement, interpretation
Reviews againstThe applicable standards for this work
FieldMatched to your topic
Dr. DivyaPhD in Life Science · second reviewer

Reviews the work independently of the first pass and reconciles the two, because most errors in this work are factual rather than errors of reasoning. Disagreements are logged and adjudicated.

OwnsIndependent second read
Reviews againstThe applicable checklist
Adjudicated byA third reviewer
Dr. AntonyProduction and delivery lead

Responsible for file formats, compliance with the destination specification and the handover of working files, so that the delivered files match what you requested.

OwnsProduction and delivery
Reviews againstThe destination's own specification
Second-checked byA second production reviewer
Mr. JohnCompliance and standards reviewer

Confirms that the work meets the standards that apply to it, whether MLR, WCAG, a regulatory guidance or the body that governs the specific deliverable.

OwnsStandards and compliance review
Reviews againstThe standards listed on this page
ToolsThe current published guidance for each

Evidence Base

The Evidence and Expertise Behind Our Medical Affairs Content Services

Each point below is sourced from published research or guidance, or owned by a named role on the team. We can direct you to the source or the reviewer on request.

01 Scale of Medical Affairs content reviewLarge MLR review providers handle thousands of materials each month using networks of subject matter experts across many therapy areas and regions, illustrating the scale and specialization at which Medical Affairs content review operates.
02 Rising content volumes and shorter review windowsMedical Affairs teams face rising content volumes, shorter review windows and increasing regulatory pressure, and review providers increasingly compete on turnaround speed in response.
03 GPP requirements for medical writer disclosureGood Publication Practice guidelines (GPP3, 2015, updated as GPP 2022 in Annals of Internal Medicine) require that medical writers be properly acknowledged rather than ghostwritten, that their role, funding and competing interests be disclosed, and that company-sponsored research follow reporting standards such as CONSORT, STROBE and PRISMA listed by the EQUATOR Network.
04 FDA guidance on unsolicited off-label requestsFDA's December 2011 draft guidance, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Docket FDA-2011-D-0868), treats how a company answers an unsolicited medical information request as a distinct regulatory question from promotional communication.

Packages

Medical Affairs Content Pricing: Published Starting Price

The published starting price below covers the standard scope; larger projects are quoted before work begins.

Standard

Medical Affairs Content

Starting price per Medical Affairs deliverable (e.g., one scientific platform document, one field medical slide deck, or one medical information response letter, up to approx. 2,500 words), including alignment to GPP 2022/ICMJE referencing norms and one MLR-ready compliance pass.

$3,200Published starting price

Delivery 5–10 business days

  • ✓Medical Affairs document (scientific platform, field medical deck, or MI response letter)
  • ✓Reference list formatted to journal/GPP 2022 standards
  • ✓Author/contributor disclosure documentation
  • ✓MLR-ready submission package
  • ✓Core claims mapping where applicable
Get a free quote

Quality Assurance

Our Service Commitment and Revision Policy

The revision commitment that applies to every project, with its scope and remedy stated in advance.

The Pubrica revision commitment

Free Revision Where Work Does Not Meet the Agreed Brief or Named Standard

Within the agreed scope, we revise at no extra cost any work that does not match the brief or a standard named on this page.

01

The brief is confirmed before production

Confirming the brief at scoping prevents misunderstandings that would otherwise require rework after delivery.

02

A named reviewer signs off before you see it

The review is made against the standards listed on this page.

03

AI use is disclosed

We tell you which tool was used, at which stage, and what a human reviewer changed afterwards.

04

You receive the working files

The material can be updated later without starting again or paying for the work twice.

Client Stories

“The content cleared MLR on the first pass, which almost never happens with an outside writer.”
PhillipsMedical affairs lead, pharmaceutical company

USA

FAQs

Frequently Asked Questions About Medical Affairs Content

If your question is not answered here, ask an expert — no quote required.

Pubrica writes medical affairs content for Medical Affairs departments at pharma and biotech companies, field medical and MSL teams, medical information teams, publications teams and market access teams. Each project delivers a Medical Affairs document (a scientific platform, field medical deck or MI response letter), a reference list formatted to journal/GPP 2022 standards, author and contributor disclosure documentation, an MLR-ready submission package and, where applicable, core claims mapping, prepared in line with Good Publication Practice (GPP 2022). Our medical writers and content strategists work in-house. A named subject specialist manages your project from brief to delivery, and a second, independent reviewer checks the work before it reaches you.

The core deliverable is a Medical Affairs document (scientific platform, field medical deck, or MI response letter); the full list appears under “Deliverables” on this page.

Large MLR review providers handle thousands of materials each month using networks of subject matter experts across many therapy areas and regions, illustrating the scale and specialization at which Medical Affairs content review operates.

This requirement is documented in published research and regulatory guidance, so our specialists address it as a defined part of every project.

The published starting price is $3,200 per Medical Affairs deliverable, such as one scientific platform document, one field medical slide deck or one medical information response letter of up to approx. 2,500 words, including alignment to GPP 2022/ICMJE referencing norms and one MLR-ready compliance pass. Any work beyond the standard scope is quoted before it begins.

Medical Affairs departments at pharma/biotech companies

Field medical/MSL (medical science liaison) teams

GPP 2022 provides recommendations for the publication of company-sponsored biomedical research, including disclosure of medical writer involvement and authorship criteria.

We apply this standard from the start of each project rather than correcting for it after a reviewer raises it.

Request a Free Medical Affairs Content Scoping Assessment

Receive a free assessment of cost, timeline and applicable standards within two business days.

Get a free quote

Regulations

Check your project against this rule

  1. 1Your work
  2. 2Your details
  3. 3Send
What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.