Five case elements
Patient identifier, suspect drug, adverse event description, reporter identification, and outcome — all present, or the case does not release.
The most rigorous ICSR a drug-safety team can receive.
Pharmacovigilance Case-Processing Engine assembles a documentation-complete Individual Case Safety Report — every statutory element, every required coding, the medical review, the E2B(R3) submission file, and the 15-day calendar — checked against the letter of 21 CFR 314.80 before a qualified reviewer releases it.
Every subsection of 21 CFR 314.80Five statutory case elements, gate-checkedMedDRA · WHO Drug · E2B(R3) codingQualified medical reviewer on every case5-business-day SLA
Why cases fail
A single missing element can trigger an inspection finding.
A drug-safety team's ICSR is only as strong as the processing behind it. Miss one of the five statutory case elements, skip a required MedDRA code, mis-time the 15-day window, or fail to assess seriousness and causality — and the submission can be rejected, flagged in an audit, or expose the sponsor to regulatory action.
Most teams run this by hand, from memory, across dozens of products. The regulation has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.
Pharmacovigilance Case-Processing Engine exists to close that gap with a single, exhaustive standard applied identically to every case.
1 of 5
missing case elements is enough to jeopardize a submission
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every case is scored against a versioned rule pack tied to the exact text of 21 CFR 314.80. These are the provisions each case is held to.
15-day window
The submission date is verified to fall no later than 15 calendar days after receipt, computed deterministically — never estimated.
Every required coding
MedDRA for adverse events, WHO Drug for concomitant medications, and E2B(R3) format for electronic submission — established by search, not assumption.
Seriousness and causality assessment
A qualified medical reviewer evaluates seriousness, causality, and expectedness against the product label and regulatory criteria.
Narrative completeness
A structured narrative including case description, relevant medical history, lab data, and chronology — drafted and verified.
Follow-up and closure
The 15-day follow-up rule, final outcome documentation, and the audit trail — sequenced on the calendar so nothing is missed.
How a case is built
Intake to reviewer release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified medical reviewer signs every release. That order is never reversed.
01
Delinquency Gap Scan
Upload the raw adverse event report and product details. We return a free completeness read: which statutory elements and coding you already have, and which are missing.
02
Evidence & coding
As your authorized clerical agent, we extract data, perform MedDRA and WHO Drug coding, and build the case narrative, corroborated across sources.
03
Grounded drafting
The five case elements are drafted from your validated data and the 21 CFR 314.80 rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Dates reconcile to the receipt timestamp; the 15-day window is verified; the coding checklist is resolved; seriousness/causality is assessed. Any failure blocks release.
05
Qualified reviewer release
A qualified medical reviewer evaluates the exception queue and signs the release. High-severity or complex cases route to senior reviewer first.
06
Delivery
You receive the case: ICSR, coding log, narrative, E2B(R3) submission file, audit trail, and the 15-day calendar — ready for the sponsor to submit under its own name.
The bar we hold
Rigor you can measure.
100%
Qualified reviewer-released
No case ships without a human signature.
5 days
Standard SLA
From complete intake to released case.
<1%
Critical-defect target
Tracked against a gold-standard case library.
4
Coding sources
MedDRA · WHO Drug · E2B(R3) · product label, every applicable file.
Why Pharmacovigilance Case-Processing Engine
Built to be the most thorough option a drug-safety team has.
Documentation-complete, by design
The deliverable is completeness itself — every statutory element and coding accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run coding as your clerical agent. We never contact the reporter, give medical advice, or submit to regulators.
Engagement
Flat fee, per released case. No contingency, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Delinquency Gap Scan before you commit — see exactly what is missing.
- One flat fee per released ICSR; disclosed pass-through coding fees.
- Optional fixed-fee senior reviewer for high-severity or complex cases.
- Optional Submission Continuity Add-on for the E2B(R3) file and follow-up, pre-dated to your 15-day window.
FAQ
Questions, answered precisely.
Is Pharmacovigilance Case-Processing Engine a law firm?
No. Pharmacovigilance Case-Processing Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Qualified medical reviewer review is available and recommended for high-severity or complex cases.
Do you contact the reporter or collect the data?
Never. Pharmacovigilance Case-Processing Engine is not a data collector and does not contact reporters or patients. The sponsor remains the responsible party for all submissions and follow-up.
What makes a case 'complete'?
Completeness is defined by the regulation: the five 21 CFR 314.80(c)(1)(i) case elements present, the 15-day window verified, the coding resolved or exception-coded, seriousness/causality assessed, and narrative complete. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a reviewer-released case. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released case, plus disclosed pass-through coding costs. No contingency and no percentage of any recovered amount or sale proceeds.
See what's missing before it costs you a submission.
Start with a free Delinquency Gap Scan. Send your raw adverse event report and product details and we'll return a completeness read against every subsection of 21 CFR 314.80.
Documentation-completeness service · not legal advice · the sponsor submits every case.