For Pharma & Biotech
Pubrica provides pharmaceutical and biotechnology companies with regulatory writing, medical communications, market access and HEOR, and biometrics, all built from one evidence core. Many submission problems come from outdated versions of standards rather than from the product: a dossier built to ICH E6(R2) when R3 is in force, a checklist submitted against CONSORT 2010, or a reimbursement submission addressed to CADTH, which has been Canada’s Drug Agency since May 2024. We write to the version currently in force and state which version we used.
- Current versions of each standard — ICH E6(R3), ICH M11, ISO 14155:2026, CONSORT 2025, GPP 2022, AMCP Format 5.0
- Regulatory, medical affairs and market access from one team, so the CSR, the publication and the payer dossier remain consistent
- EU Joint Clinical Assessment, live since 12 January 2025, with every consolidated PICO answered inside the 100-day window
- Biometrics through to submission: analysis plans, CDISC SDTM and ADaM, Define-XML and the reviewer guides
- Service limits stated in advance — the work we do not undertake is listed on this page
Regulatory writing, current versionsIncluded
Medical affairs and publicationsIncluded
Market access and HEORIncluded
CDISC datasets and reviewer guidesIncluded
Acting as your MLR reviewerMust be your own staff
Data → dossier → published → assessed → reimbursed
- Written to the version in force
- The version used is named
- One evidence core across functions
- Service limits stated in advance
- Working files handed over
Our Services
Regulatory, Medical Affairs, Market Access and Biometrics Services
The same data appear in all four types of document, so commissioning them from one team keeps the numbers consistent.
Version accuracyWe use ICH E6(R3) rather than R2, PBRER under E2C(R2) rather than the superseded PSUR terminology, and CTIS rather than EudraCT. These details show a reviewer that a document is up to date.
Disclosure of writing supportGPP 2022 recognises professional medical writing as legitimate and common. The compliance requirement is to disclose the writer’s contribution.
EU Joint Clinical AssessmentJCA has applied since 12 January 2025 to new oncology active substances and ATMPs; orphan products from January 2028 and all centrally authorised medicines from January 2030.
Technical validationTechnical validation must be passed before the product is assessed, and failures at this stage usually result from version mismatches rather than the science.
Samples are illustrative and anonymised. Hover any one of them to play it again.
Compliance and Standards
Regulatory, Publication and HTA Standards
We name the version of each standard we apply, because outdated versions cause many submission problems.
Good clinical practice (with ICH M11 at Step 4)
The R3 revision puts data governance and risk-proportionate quality at the centre. ICH M11 reached Step 4 on 19 November 2025 and sets the clinical protocol template.
GPP 2022 (good publication practice)
The 2022 update replacing GPP3. Covers company-sponsored research including real-world evidence, and extends to preprints, plain language summaries and social media.
Joint Clinical Assessment (live since 12 Jan 2025)
Consolidated PICOs set by the assessors, a 100-day dossier window, and a single clinical assessment every Member State must give due consideration to. Pricing stays national.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
How It Works
How a Pharma or Biotech Programme Works
Each project starts by establishing which versions apply to your programme, because that determines most of the work.
Versions and scope
We establish and state the standards, guidance versions and agency expectations that apply to your programme before drafting begins.
One evidence core
The systematic review, comparisons and analysis are built once, so every downstream document uses the same numbers.
Documents
Each document is written to the structure its reader assesses against, with the version used named in the document.
Handover
Working files, models, programs and search strategies are delivered to you, because clarification-round deadlines are your responsibility.
FAQs
Questions from Pharma and Biotech Teams
If your question is not answered here, ask an expert — no quote is required.
Not as a published service at present. We provide project and programme work and do not describe a resourcing model we have not defined.
If you need an embedded arrangement, tell us the requirements, including dedicated or fractional support, minimum term and governance, and we will tell you whether we can meet them.
No. We can prepare, annotate and reference an MLR submission pack, which is substantial work. The review itself has to be your own qualified staff.
A supplier cannot act as an independent reviewer of material it prepared, whatever the contract states.
One evidence core. The systematic review, the indirect comparisons and the analysis are built once, and the CSR, the publication, the JCA dossier and the payer submission all draw from it.
When documents are split across suppliers, the same endpoint can be described in different ways, and assessors who read more than one document notice the inconsistency.
We use signed confidentiality agreements, limit access to the assigned team, transfer files with encryption, and do not use client material to train any system or share it with third-party tools.
Unblinded datasets and pre-submission documents are handled under the same terms as everything else.
Related services
Related Audiences and Services
Services for clients with related evidence needs.
1IF YOU MAKE DEVICESdifferent regulation
Medical device and IVDMDR and IVDR technical files. Clinical evaluation reportAssessed by a notified body.2IF YOU ARE ACADEMIC-SPONSOREDinvestigator-initiated
Universities and institutionsSponsor-investigator studies. Clinical trial supportSupport across the study.3SERVICE FAMILIESfull service list
Regulatory writingThirteen document types. Market access and HEORPayer submissions, HTA and pricing.Request a Free Gap Analysis for Your Programme
Tell us your programme and target markets. You will receive a list of what transfers, what must be rebuilt, and what must be decided before a trial locks.