Case intake and triage workflow
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
“
Submitted
ICSR Workflow
StatusSubmitted
Our craft
Built around real pharmacovigilance practice.
Service Detail
Move ICSRs from intake to compliant submission.
PharmaRevix supports ICSR receipt, triage, processing, narrative authoring, medical and quality review, and timely submissions to authorities and partners.
You need outsourced ICSR processing
You have expedited reporting timelines to manage
You need backlog review or remediation
You need partner and authority submissions tracked
Deliverables
Practical outputs your team can use immediately.
Narrative and coding package
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Medical and quality review record
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
E2B submission tracking log
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Follow-up request and closure tracker
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
SLA and compliance dashboard
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Workflow
A clear sequence from assessment to handoff.
01
Assess
Receive and validate minimum case information
02
Plan
Assess seriousness, expectedness, and reportability
03
Execute
Process, code, narrate, and quality-review the case
04
Maintain
Submit, follow up, and archive compliance evidence
Proof Package
Every engagement leaves an evidence trail.
The work is designed for real review: authority questions, partner due diligence, quality audits, and internal leadership updates.
E2B15-daySenior-led
ICSR intake and triage from all sources
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Narrative authoring and MedDRA coding support
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Medical and quality review
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Timely E2B submissions and follow-up case handling
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Related Services
Connect this work with adjacent regulatory and safety needs.
QPPV & Local Representative Services
PharmaRevix provides EU and UK QPPV, Deputy QPPV, Local Safety Officer, Contact Person, and local representative support where required by national legislation.
Explore serviceLiterature Screening & Management
PharmaRevix performs global and local literature monitoring for adverse drug reactions, safety signals, and relevant medical literature in line with FDA, EMA, and ICH expectations.
Explore serviceAggregate Reports Writing
PharmaRevix authors PSUR, PBRER, PADER, ACO, and other periodic safety reports with data coordination, medical assessment, quality review, and final submission support.
Explore serviceFAQ
Common questions about Case Processing & Submission.
Short answers for teams deciding whether this is the right next step.
Ask us anythingCase processing covers ICSR receipt, triage, assessment, narrative authoring, medical and quality review, and timely authority or partner submissions.
PharmaRevix supports this with senior review, practical documentation, and a clear evidence trail so the output can be used by internal teams, partners, and authorities.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
Free 30-minute consultation
Need case processing & submission support?
Talk with PharmaRevix about scope, timelines, and the cleanest next step for your market or safety obligation.