What is a regulatory systematic review service and how is it different from a standard literature review?

It is a protocol-driven literature review built specifically for regulatory submissions, so it is audit-ready and fully traceable rather than interpretive. Unlike a standard academic review, every search string, screening decision, and appraisal judgment is documented and reproducible, allowing an inspector or notified body to reconstruct exactly what was done and why long after sign-off.

Do you conduct Clinical Evaluation Report (CER) literature reviews under EU MDR?

Yes. We conduct CER literature reviews following MEDDEV 2.7/1 Revision 4 under the EU Medical Device Regulation (EU MDR) 2017/745, covering both the state-of-the-art review that establishes the clinical context and the systematic identification and appraisal of clinical data for the subject device and any claimed equivalent devices. The output feeds the benefit-risk determination that your clinical evaluator and notified body will assess.

Can you support PSUR literature searching and pharmacovigilance signal detection?

Yes. We run interval literature searches for Periodic Safety Update Reports (PSUR) on a fixed, repeatable protocol under Good Pharmacovigilance Practices (GVP), and we provide signal detection support through reproducible searches that surface case reports and emerging safety associations. Because the method is pre-specified and logged, both the presence and the documented absence of a signal are inspection-ready.

Will the review be defensible if we are audited or receive questions months later?

That is the design goal. We treat the full audit trail as a deliverable: the version-controlled protocol, dated search logs per database, deduplication record, screening decisions with exclusion reasons, appraisal worksheets, extraction tables, and reference set are all preserved and cross-referenced. Any statement in the report can be walked back to its source, so post-submission questions are answered from the file.

Do you guarantee that our submission will be approved?

No, and we are explicit about this. We provide methodological and evidence-synthesis support only. We do not act as your regulatory representative, we do not make regulatory determinations, and we cannot guarantee that any competent authority or notified body will accept a submission. What we stand behind is method: a defensible protocol, a reproducible search, a transparent appraisal, and a complete audit trail.

Do you report to PRISMA and GRADE?

Where those standards apply, yes. We report the flow of records to PRISMA so identification through inclusion is transparent, and we align certainty-of-evidence language with GRADE where a graded judgment strengthens the narrative. For device work under MEDDEV 2.7/1 Revision 4 we follow the appraisal and weighting methodology that guidance sets out.

How do you handle confidentiality, purchase orders, and NDAs for institutional clients?

Pharmaceutical, biotech, and medical device clients typically engage us under a non-disclosure agreement, against a purchase order, and within a written scope of work that names deliverables, reporting standards, databases, date ranges, and the accountable methodologist. Unpublished protocols, proprietary safety data, and pre-submission strategy are kept strictly confidential. NDA and purchase-order terms are available on request.

Who is the named methodologist accountable for this work?

Methodological oversight for pharmaceutical and regulatory reviews is provided by Dr. Elena Vasquez, a PhD methodologist in clinical epidemiology. Every institutional engagement names the accountable methodologist in the written scope of work so you know who is responsible for the protocol, the search, and the appraisal.

Regulatory Systematic Review Service

Regulatory Systematic Review Service for Pharmaceutical, Biotech, and Medical Device Submissions

A regulatory systematic review service delivers protocol-driven, audit-ready literature reviews that support regulatory dossiers, safety documentation, and market authorization filings for medicines, biologics, and medical devices. Research Gold plans and executes these reviews as structured literature reviews for regulatory submissions: every search is pre-specified, reproducible, and fully documented, every screening and appraisal decision is traceable, and the final report is built to withstand inspection by a competent authority, notified body, or internal quality function. Methodological oversight for this service is provided by Dr. Elena Vasquez, a PhD methodologist in clinical epidemiology. We provide methodological and evidence-synthesis support; we do not make regulatory determinations and we do not guarantee approvals.

How Regulatory Reviews Differ From Academic Reviews

The distinction that matters most to a regulatory affairs team is not the search itself but the audit trail wrapped around it. An academic review is judged on novelty and interpretation. A regulatory review is judged on traceability and defensibility: can an assessor reconstruct exactly what you searched, when, why, what you excluded, and on what basis, months or years after the work was signed off. That standard changes the working method from the first day, because anything that cannot be reconstructed later has to be avoided from the start.

That difference shapes everything we do. A pre-specified protocol is written and version-controlled before the first database is queried, so scope, eligibility criteria, and appraisal rules are fixed in advance rather than adjusted to fit a preferred conclusion. Search strings are recorded verbatim per database with dates, hit counts, and platform versions. Screening is captured at both title-abstract and full-text stages with reasons for exclusion logged against named records. Every claim in the narrative maps back to an identified source. This is what an inspector or a notified body reviewer means when they ask for a , and it is the reason a submission-grade review costs more effort than a conventional literature survey. It also means the method is portable across your product portfolio: once a protocol template and search architecture are validated, they can be reapplied consistently to the next indication, device, or reporting cycle without relitigating first principles each time.

Literature Reviews for Pharmacovigilance and Safety

On the medicinal-product side, structured literature searching is a standing obligation, not a one-time exercise. Under Good Pharmacovigilance Practices (GVP), marketing authorization holders must monitor the scientific literature systematically for safety information, and the review methodology has to be documented well enough to reconstruct on request.

Signal Detection Support

We provide signal detection support through reproducible literature searches designed to surface case reports, case series, observational findings, and emerging safety associations that may constitute a signal. The value of a defensible method here is direct: when a search is pre-specified and logged, the absence of a signal is as documentable as its presence, and both positions are inspection-ready.

PSUR Literature Searching

For the Periodic Safety Update Report (PSUR), we run interval literature searches on a fixed, repeatable protocol so that each reporting period is covered consistently and the cumulative safety picture is coherent across submissions. Search parameters, databases, date windows, and screening outcomes are recorded so that the PSUR literature searching methodology stands up to assessment and can be rerun identically in the next cycle.

Benefit-Risk Framing

Across both the device and medicinal-product contexts, safety evidence has to be placed in a benefit-risk frame rather than presented as an isolated list of findings. We structure the synthesis so that identified risks are weighed against demonstrated benefit in the specific intended-use population, giving the assessor a reasoned balance rather than an undifferentiated catalogue of literature. For products where access and value evidence also matter, this connects to our health technology assessment and market access work, though we keep the regulatory synthesis and the value synthesis methodologically distinct.

The Audit Trail Is the Deliverable

For inspection purposes, the review report and the evidence behind it are one object. We treat the full audit trail as a first-class deliverable, not a byproduct. That means the protocol, the dated search logs per source, the deduplication record, the screening decisions with exclusion reasons, the appraisal worksheets, the extraction tables, and the reference set are all preserved and cross-referenced so that any statement in the report can be walked back to its origin.

This discipline is what lets a submission survive a question that arrives eighteen months after sign-off: show us that this search would have found the pivotal study, and show us why these three records were excluded. When the reproducible and documented search and the transparent appraisal are captured properly the first time, that question is answered from the file, not reconstructed from memory.

Confidentiality, Purchase Orders, and Scope

Institutional work carries institutional requirements, and we structure engagements accordingly. Pharmaceutical, biotech, and medical device clients typically work with us under a non-disclosure agreement (NDA), against a purchase order, and within a written scope of work that names the deliverables, the reporting standard, the databases and date ranges, and the methodology reviewer accountable for the work. For this service that named PhD methodologist is Dr. Elena Vasquez.

We keep unpublished protocols, proprietary safety data, device technical information, and pre-submission strategy strictly confidential, and we align our documentation practices with the record-keeping expectations that quality and regulatory functions operate under. Pricing is scope-driven and fixed at quote; there is no per-region variation and no charge tied to the outcome of any submission.

To be unambiguous about what we do and do not provide: Research Gold delivers the evidence synthesis and the methodological rigor behind a regulatory literature review. We do not act as your regulatory representative, we do not make regulatory determinations, and we do not guarantee that any authority or notified body will accept a submission. What we stand behind is method: a defensible protocol, a search you can reproduce, an appraisal you can defend, and an audit trail you can hand to an inspector.

Start With a Scoped Conversation

Every regulatory engagement begins with scope, because the right method depends on whether you are building a CER under EU MDR, supporting an SLR inside a dossier, standing up PSUR searching under GVP, or assembling a state-of-the-art review to frame a device claim. Tell us the submission context, the applicable standard, and the timeline, and we will map the methodology, the reporting format, and the documentation package to it. When you are ready, request a scoped quote and we will respond with a written proposal, a named methodologist, and NDA and purchase-order terms on request.

Regulatory Systematic Review Service for Pharmaceutical and Medical Device Submissions

Regulatory Systematic Review Service for Pharmaceutical, Biotech, and Medical Device Submissions

How Regulatory Reviews Differ From Academic Reviews

Our pharmaceutical and regulatory literature review process

Scope and protocol

Documented search

Screening and appraisal

Synthesis and write-up

Audit trail

Every pharmaceutical and regulatory literature review order ships with

What clients say about our pharmaceutical and regulatory literature review

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Systematic Literature Reviews Supporting Regulatory Dossiers

Clinical Evaluation Report Literature Reviews Under EU MDR

State-of-the-Art Reviews

Appraisal of Clinical Data