Reporting calendar and data request list
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
“
QC complete
PBRER Pack
StatusQC complete
Our craft
Built around real pharmacovigilance practice.
Service Detail
Turn periodic safety data into authority-ready reports.
PharmaRevix authors PSUR, PBRER, PADER, ACO, and other periodic safety reports with data coordination, medical assessment, quality review, and final submission support.
You need PSUR or PBRER writing capacity
You need FDA PADER or local aggregate reports
Your data sources need reconciliation
You need medical and quality review discipline
Deliverables
Practical outputs your team can use immediately.
Line listing and summary integration plan
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Benefit-risk narrative and medical assessment
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Quality review and reconciliation record
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Final submission-ready report
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Response support for authority questions
Practical, reviewable, and ready for the owner who needs to act, approve, or respond.
Workflow
A clear sequence from assessment to handoff.
01
Assess
Confirm report type, data lock point, and reporting interval
02
Plan
Collect cases, exposure, literature, signals, and actions
03
Execute
Draft medical assessment and benefit-risk narrative
04
Maintain
Quality-review, finalize, and submit or hand off
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.
PSURPADERSenior-led
PSUR and PBRER authoring per ICH E2C(R2)
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
PADER and ACO authoring for applicable markets
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Medical and quality review coordination
Captured with owners, assumptions, decision rationale, and next actions so the work can continue smoothly.
Final report package for client and authority submission
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.
Case Processing & Submission
PharmaRevix supports ICSR receipt, triage, processing, narrative authoring, medical and quality review, and timely submissions to authorities and partners.
Explore serviceSignal Management
PharmaRevix supports signal detection scheduling, validation, prioritization, evaluation, QPPV safety review, and documentation aligned with GVP Module IX.
Explore serviceRisk Management Plans & Mitigation
PharmaRevix authors and updates EU-RMPs, US REMS-supporting content, risk minimization measures, and educational materials for healthcare professionals and patients.
Explore serviceFAQ
Common questions about Aggregate Reports Writing.
Short answers for teams deciding whether this is the right next step.
Ask us anythingAggregate report writing brings case data, literature signals, benefit-risk evaluation, medical review, and final submission support into one controlled periodic reporting process.
Yes. PharmaRevix can scope this as a standalone workstream or connect it with adjacent regulatory affairs, pharmacovigilance, QMS, and submission activities.
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.
Free 30-minute consultation
Need aggregate reports writing support?
Talk with PharmaRevix about scope, timelines, and the cleanest next step for your market or safety obligation.