Scientific Review & AQP Services
Reference verification, claim substantiation, data consistency and evidence logic — with a structured written report for every material reviewed. Catches unsupported claims before they reach the signatory, or before they reach the PMCPA.
Discuss a Review Engagement →The problem
When the same team has worked on a material through multiple rounds of development, they stop seeing what is actually on the page. They see what they expect to be there. Independent scientific review exists because internal familiarity is a structural weakness — not a failure of diligence.
Internal reviewers correct the claim wording but do not always verify whether the underlying reference actually supports what the claim now says. By the time a material reaches the signatory, everyone assumes it has been thoroughly checked. It often has not been.
Medical writers produce draft claims in good faith. But thorough source verification — checking that the figure quoted matches the paper cited, that confidence intervals are correctly reported, that comparative claims have direct head-to-head data — takes time that internal teams frequently do not have.
The standard applied in a PMCPA investigation is exacting. A claim may look reasonable to someone familiar with the data but be demonstrably misleading when the referenced source is read literally. That gap between internal comfort and external scrutiny is where complaints originate.
Website copy frequently contains outcome statistics and efficacy claims that were accurate when first drafted and have never been cross-referenced against the current label or the cited publication since. Digital content is long-lived. An error can remain in public view for months.
What's included
Every scientific review engagement delivers a structured written report. Not a list of comments — a methodical record of each issue found, the source reference it was checked against, and the recommended correction.
Every referenced claim is checked against the cited source. Figures, percentages, confidence intervals, p-values, and patient population descriptors are verified against the original data. Discrepancies are flagged with the specific location in the source document.
Each promotional claim is assessed against the quality and level of the evidence cited to support it. Comparative superiority claims, absolute vs relative risk presentations, and indirect comparisons receive particular scrutiny against ABPI Code Chapter 14 requirements.
Statistics presented across multiple sections of the same material — or across a suite of related materials — are cross-referenced for internal consistency. Inconsistent data presentation is a frequent source of PMCPA findings and is often missed in round-by-round review.
Promotional materials are reviewed for appropriate reflection of the benefit-risk profile, including the prominence and completeness of adverse event and contraindication information relative to efficacy claims, in line with ABPI Code requirements for fair balance.
Every review produces a formal written report. Each finding is documented with: the location in the material, the nature of the issue, the source reference consulted, the specific discrepancy identified, and a recommended correction. The report stands as an audit document.
Available as a standalone pre-submission review, as a parallel review alongside your signatory process, or embedded within your MLR workflow. Works via Veeva Vault, ZINC, or structured email. Scope and workflow discussed on enquiry.
What you receive
The written review report is designed to be an actionable document, not a list of concerns. Each finding has everything the reviewer needs to make a correction without going back to the source material themselves.
All cited references are identified and sourced. Materials submitted without a full reference pack are flagged — missing references are themselves a finding.
Each claim is checked against its cited source. Figures, statistics, and qualitative claims are verified for accuracy and appropriate context.
All findings are documented in a structured report with location, issue, source, discrepancy, and recommended correction for each item.
The report is delivered directly to the review owner or submitted within your MLR platform. Urgent timelines are discussed on enquiry.
What clients say
“We had a detailed JLA that had been through three internal rounds. Anzal found four unsupported claims and two data errors in the first pass. Two of those were figure discrepancies against the primary endpoint data. It would have been a PMCPA complaint.”— Medical Director, UK affiliate
“Having an independent scientific reviewer as a pre-signatory step catches things that internal teams miss because of familiarity blindness. You stop seeing the material after you have reviewed it four times. An independent reviewer sees it for the first time every time.”— Regulatory Affairs Manager, mid-size pharma company
Who this is for
Scientific review is most valuable in situations where the cost of a mistake is high — product launches, high-profile campaigns, complex efficacy claims, or materials that will be widely distributed to HCPs.
MSL resources, congress abstracts, and medical education materials where scientific accuracy and appropriate balance are both required and heavily scrutinised.
Teams responsible for sign-off who want independent pre-signatory verification — particularly for materials with complex efficacy data or indirect comparisons.
Pre-launch promotional materials reviewed before the signatory step — when the cost of rework is highest and the pressure to move quickly is greatest.
Website copy and digital materials that contain efficacy or outcome statistics — particularly content that has been live for an extended period without re-verification against current data.
Smaller UK affiliates where the medical writer producing the claim is the same person expected to verify it — creating an inherent conflict of interest in the review process.
Companies that have received a complaint and need to review their current materials portfolio for similar issues before the PMCPA investigation broadens its scope.
Common questions
Promotional materials of all formats, medical education content, MSL resource packs, website and digital copy, congress abstracts and poster content, and briefing documents containing clinical claims. If it contains a referenced scientific or efficacy claim aimed at an HCP audience, it is within scope.
Yes, without exception. The written report is the core deliverable of the engagement. Every finding is documented with: the location in the material, the nature of the issue, the reference consulted, the specific discrepancy identified, and a recommended correction. It serves as a complete audit record of the review.
Yes. Reviews can be submitted and returned within Veeva Vault PromoMats, ZINC, or similar platforms. Where a formal MLR system is not in use, review can be conducted via structured email exchange with version control. The workflow is confirmed on enquiry.
Typically two to three business days per material set. The exact timeline depends on the number of materials, the complexity of the evidence base, and the completeness of the reference pack provided. Urgent reviews are accommodated where possible — timelines are discussed at the point of enquiry.
Get in touch to discuss your current review volume, material types, and how independent scientific review can be integrated into your process.
Discuss a Review Engagement →Need instant answers?
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