Pharmaceutical & Regulatory
This service is designed for teams whose evidence will be scrutinized. Whether you are assembling the clinical evidence base for a drug or therapeutic area, preparing a structured literature review to support a scientific or regulatory document, or producing a peer-review-ready manuscript on a pharmaceutical intervention, the methodological rigor of the review is what determines whether it withstands review. We build for that level of scrutiny from the protocol stage.
We work to the Cochrane Handbook for Systematic Reviews of Interventions (version 6.5, 2024), the PRISMA 2020 Statement (Page et al., BMJ, 2021), and the GRADE framework for certainty of evidence. Where a review supports a regulatory or reimbursement context, we align the methodology to the expectations of the relevant body and document every decision for audit.
Pharmaceutical and regulatory evidence synthesis is a different discipline from an academic literature review. The questions are often comparative, the evidence base includes trial registries and grey literature, and the output must be reproducible and defensible to a third party. We support:
Medical affairs and medical writing teams who need a structured or systematic literature review to underpin a scientific narrative, a publication, or an internal evidence assessment, and who need it built to a methodology that will survive external review.
Regulatory and clinical development teams who require a comprehensive, reproducible evidence base for a specific drug, comparator, indication, or safety question, with a search strategy and screening process that can be documented and audited.
Pharmacovigilance and safety teams who need a systematic search and synthesis of the published evidence on adverse events, drug interactions, or post-marketing safety signals.
Health economics and outcomes research (HEOR) teams who need the clinical systematic review component that feeds an economic model or an indirect comparison. For reviews intended specifically for reimbursement and HTA submissions, see our HTA and market access service.
Biotech and small pharma without an in-house evidence function who need the rigor of a dedicated evidence synthesis team without building one internally.
A systematic review that supports a regulatory, safety, or scientific decision is held to a higher standard than one written for a course or a low-stakes publication. The reader is looking for reasons to doubt it. A search that is not reproducible, a screening process without documented dual review, a risk of bias assessment that uses the wrong tool, or a synthesis that overstates certainty are not just academic weaknesses. In a regulatory or evidence-assessment context, they are the points on which the review is challenged.
The most common failures we are asked to correct in pharmaceutical evidence work are the same ones that cause journal rejection, amplified by the stakes: incomplete or non-reproducible search strategies that miss relevant trials, single-reviewer screening that introduces selection bias, missing or incorrectly applied risk of bias assessment, heterogeneity that is reported but not explored, and conclusions that the certainty of evidence does not support. Our process is built to close each of these gaps by default and to document the closure so it is visible to a reviewer.
We do not replace your scientific or regulatory judgment. We provide the methodological execution, fully documented, so your team can stand behind the evidence base with confidence and account for every decision in it.
The search and screening stages can also be commissioned on their own through our search strategy service and our screening and data extraction service.
| Need a defensible evidence base for a pharmaceutical or regulatory question? |
|---|
Tell us about your therapeutic area, question, and intended use. A PhD methodologist will respond with a scoped proposal and a confidentiality agreement on request, or chat on WhatsApp. Request a Scoped Quote |
We do not use proprietary or self-created methodology. Every review follows established, recognized standards so the evidence base is defensible to any reviewer.
| Dimension | Academic Systematic Review | Pharmaceutical / Regulatory SLR |
|---|---|---|
| Primary purpose | Publication or thesis | Evidence base for a scientific, regulatory, safety, or reimbursement decision |
| Evidence sources | Published literature | Published literature, trial registries, grey literature, unpublished data |
| Reproducibility standard | Expected by journal | Auditable; every decision documented for third-party scrutiny |
| Comparator handling | Often single intervention | Frequently comparative; may require indirect comparison |
| Confidentiality | Usually not required | NDA standard; data and outputs treated as confidential |
| Certainty reporting | GRADE encouraged | GRADE expected; conclusions strictly calibrated to evidence |
Pharmaceutical and regulatory reviews are scoped individually rather than sold at a fixed price, because the work depends on the breadth of the question and the standard the output must meet. We provide a detailed, itemized proposal after a short scoping conversation. The drivers that determine scope and cost are:
We provide a custom quote per project. Tell us the therapeutic area, the question, and the intended use, and we will return a scoped proposal with deliverables, timeline, and an itemized cost. A confidentiality agreement is available before you share any details. Request a Scoped Quote.
All pharmaceutical and regulatory engagements are covered by a mutual confidentiality agreement as standard. We do not disclose client identities, therapeutic areas, project details, or any aspect of the evidence work to third parties. An NDA is available before any project details are shared.
ScribeLabWriter provides methodological and evidence synthesis support consistent with ICMJE recommendations and GPP (Good Publication Practice) principles where the output is intended for publication. Where our work contributes to a manuscript, our role is acknowledged or declared transparently, and your team retains full scientific and intellectual accountability for the evidence and its interpretation. See our ethics and integrity policy, and our country and regulatory standards guide for region-specific expectations.
We produce the systematic literature review and evidence synthesis components to a reproducible, audit-ready standard suitable for inclusion in regulatory and scientific documentation. We build the methodology, search, screening, appraisal, and synthesis to recognized standards (PRISMA 2020, Cochrane, GRADE) and document every decision. The regulatory strategy, the final submission assembly, and the regulatory accountability remain with your team. Tell us the intended use in your enquiry and we will scope the documentation standard accordingly.
Yes. A mutual confidentiality agreement is standard for pharmaceutical and regulatory work, and we can put one in place before you share any therapeutic area or project specifics. Confidentiality is the default for every engagement in this service.
Yes. For pharmaceutical evidence, searching trial registries (ClinicalTrials.gov, WHO ICTRP, EU CTR), conference proceedings, and other grey literature is essential to reduce publication bias, and we include these sources where the question requires them. The exact sources are defined in the protocol.
Yes. Where direct comparison is not possible, an indirect treatment comparison or network meta-analysis may be appropriate. We assess feasibility and, where suitable, deliver the analysis through our meta-analysis service. If the review supports a reimbursement or HTA context specifically, our HTA and market access service is the better starting point.
Every engagement is led by a PhD-qualified methodologist and, where statistical synthesis is involved, a biostatistician with relevant experience. We do not use AI-generated content, and we do not outsource to generalist writers. The team is matched to your therapeutic area and the methodological demands of the question.
We scope and price each project individually based on the number of questions, the breadth of the search, the comparator structure, the synthesis depth, the documentation standard, and the timeline. We provide a custom, itemized quote per project after a short scoping conversation. There is no fixed list price because the work is not standardized.
Submit your details through our pharmaceutical and regulatory enquiry form. Include your therapeutic area, your research or evidence question, the intended use of the review, and your timeline. A PhD methodologist will respond within 2-4 business hours with a scope assessment and next steps. A confidentiality agreement is available on request before you share project details.
Tell us your therapeutic area, question, and intended use. A PhD methodologist will respond within 2-4 business hours with a scoped proposal, timeline, and itemized cost. Confidentiality agreement available on request.
Prefer email? Send your project details to info@scribelabwriter.com
