Industry Evidence and Regulatory Submission Services
Pubrica prepares regulatory, device, market access and medical communications documents for pharmaceutical, medical device and diagnostics companies whose submissions will be assessed by a regulator, a notified body or a payer. Our regulatory and medical writers prepare study reports, protocols, device files and payer dossiers to the version of the rules currently in force, and we name that version in each document. Where you use more than one of these services, we maintain one consistent description of your evidence across all of them, so that assessors reading different documents find the same account.
- The current version, named in the document: ICH E6(R3), MDR, IVDR and the current HTA guidance, rather than the version an older template was built on
- One evidence core across submissions, so that the regulatory dossier, the payer dossier and the publications are consistent with one another
- Scoped and quoted per programme, because these documents have no per-word unit and a published unit price would be misleading
- Responsibilities stated in advance: we prepare the documents, your qualified staff approve them, and we confirm this division before work starts
- Medical devices treated as a separate framework rather than as an adaptation of pharmaceutical requirements, which is a common source of notified-body deficiencies
A regulatorRegulatory writing
A notified bodyMedical device & IVD
A payer or HTA committeeMarket access & HEOR
A prescriber, through the fieldMedical communications
Not yet definedDiscovery & intelligence
Evidence → one core → each framework → assessed consistently
- The standard named at the version in force
- One evidence core behind every submission
- Scoped and quoted per programme, never per word
- Preparation and approval kept separate in writing
- Working files and models handed over
Deliverables
Six Regulatory and Industry Evidence Service Areas
Organisations often need two or more of these service areas at the same time, and this group is organised to support that.
Evidence assessment before planningAn evidence gap that is discovered while the protocol is being written is the most costly problem in programme planning.
Written for its intended readerThe same data written for a journal, a regulator and a court results in three different documents rather than one document reformatted.
For medical affairsPublication planning to GPP 2022, with governance documented so that the plan withstands audit.
For a regulatorICH M11 reached Step 4 in November 2025. Protocol templates built before that date need to be reconciled with it rather than reissued.
For a notified bodyA clinical evaluation plan must be approved before the report is written. A CER written without an approved CEP is the first deficiency assessors raise.
For a payerEU JCA has applied to oncology new active substances and ATMPs since January 2025, with a hundred-day dossier window, so the timetable is the main constraint.
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Compliance and Standards
Regulatory Frameworks Applied at the Current Version
Each of these frameworks is revised periodically. Working to a superseded version is a correctable finding, but it still causes a delay.
ICH (for pharmaceutical submissions)
E6(R3) rather than R2, and M11 at Step 4 since 19 November 2025. We name the version in each document.
MDR and IVDR (for devices and diagnostics)
Annex XIV for clinical evaluation, Annex XIII for performance evaluation, and Articles 83 to 86 for surveillance and periodic reporting by class.
HTA Regulation (for European market access)
In force since 12 January 2025 for oncology new active substances and ATMPs, for orphan medicines from January 2028 and for all centrally authorised medicines from January 2030.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified system for running, recording and releasing project work.
Our Process
Regulatory Programme Process
The first step addresses the planning decisions that, if made incorrectly, cause the most costly problems later.
Confirming the frameworks
We confirm which regulators, notified bodies and payers are involved and what each currently requires, as several requirements have changed in the last eighteen months.
Building one evidence core
We prepare a single description of the endpoints, the population and the effect, from which each submission is written. This prevents contradictions between documents.
Writing to each framework
We present the evidence core in the structure each assessor expects and name the applicable version in each document.
Keeping documents current
We incorporate post-market data, new evidence and guidance revisions, because these files continue to be updated after submission.
FAQs
Regulatory and Industry Evidence FAQs
If your question is not listed here, ask an expert. No quote is required.
These services have no standard unit. An HTA dossier, a clinical evaluation report and a publication plan are scoped by programme, so a published price would be misleading rather than transparent.
Instead, you receive a written scope with the assumptions stated, so that you can see what would change the price.
No. We can prepare, annotate and reference the pack, but the review must be carried out by your own qualified staff. This boundary is written into the agreement.
Yes. In such cases, the consistency of the evidence core across suppliers needs particular attention, because assessors look for contradictions between documents, and this group is organised to prevent them.
Yes. We work in your templates, document management system and review workflow.
Related Services
Other Pubrica Service Groups
These service groups are organised for other readers and draw on the same specialists.
1PUBLISHING IN JOURNALSfive service areas
Publishing in journalsWriting and publication support for journal articles. Research servicesStudy design, evidence synthesis and statistics.2EDITORIAL SUPPORT FOR PUBLISHERSthree service areas
Editorial support for publishersEditorial support for journals and publishers.Request a Free Regulatory Programme Assessment
We will identify which of the six service areas you need and in what order, and tell you clearly if a deadline cannot be met.