From Adverse Event to Regulatory Submission.
Every Signal Accounted For.
Pharmacovigilance specialists bridging pharmaceutical companies and regulators — turning raw post-market data into structured safety narratives that keep drugs on the market and patients protected.
Five Service Spokes
PV Lifecycle
Regulatory Bodies We Work With
Spoke 01 — Case Processing
Zero ICSRs missed. Every adverse event coded, assessed, and submitted before deadline.
Regulatory Problem
EMA flags high-impact coding errors in routine inspections and mandates corrective action plans within 15 days. Inconsistent MedDRA coding across sites creates downstream signal noise, and missed 7/15-day expedited reporting deadlines carry immediate regulatory consequences.
Our Methodology
Each ICSR passes through a four-stage quality gate: structured intake validation (all four ICH elements confirmed), dual-coder MedDRA assignment using current SMQs, causality assessment against WHO-UMC criteria, and pre-submission QC against agency-specific templates. No case exits the queue without a documented audit trail.
Validated Platforms
Process Workflow
PV Lifecycle
Spoke 02 — Signal Detection
Validated signals separated from statistical noise — before the regulator finds them first.
Regulatory Problem
EMA GVP Module IX and FDA 21 CFR Part 314.81 require fully traceable signal management documented at every stage. The core operational challenge: distinguishing genuine safety signals from false positives in high-volume spontaneous reporting databases while meeting 15-day alert report mandates for serious signals.
Our Methodology
Quantitative signal detection using PRR, ROR, BCPNN, and IC metrics across integrated safety databases. Every signal enters a documented triage pipeline: statistical generation → clinical validation → regulatory triage → disposition decision. All steps time-stamped and audit-trailed to GVP Module IX standards.
Validated Platforms
Process Workflow
PV Lifecycle
Spoke 03 — PBRER/PSUR Authoring
ICH E2C(R2)-compliant periodic reports delivered within 70 days of the Data Lock Point.
Regulatory Problem
PBRERs span ~20 sections requiring synchronized data from global safety databases, clinical trials, literature, and real-world evidence. Sponsors face difficulty aggregating data across jurisdictions, meeting 70-day (6-month) and 90-day (annual) DLP deadlines, and preparing comprehensive benefit-risk narratives that satisfy simultaneous EMA and FDA review.
Our Methodology
Structured PBRER production using ICH E2C(R2) templates with dedicated workstreams for data aggregation, signal integration, clinical summary authoring, and cross-functional review. IRIS platform compliance for EMA submissions from January 2025. eCTD-formatted deliverables with complete version history and QA sign-off documentation.
Validated Platforms
Process Workflow
PV Lifecycle
Spoke 04 — Audit Readiness
Every document in sequence. Every version controlled. Zero deficiency letters.
Regulatory Problem
Cross-document alignment failures — PBRER content inconsistent with RSI, RMP, or prior reports — are among the most common triggers for agency deficiency letters and follow-up inspections. Without validated EDMS infrastructure and agency-specific QC checklists, organizations face preventable re-work cycles that delay approval timelines.
Our Methodology
Systematic pre-submission audit simulation against FDA, EMA, and MHRA inspection frameworks. Cross-document consistency matrix verification (PBRER ↔ RSI ↔ RMP ↔ previous reports). EDMS configuration review for version control and 21 CFR Part 11 traceability. Expert + QA dual sign-off protocol before any regulatory submission.
Validated Platforms
Process Workflow
PV Lifecycle
Spoke 05 — System Validation
Every platform audit-trailed. Every validation protocol executed. No system risk left undocumented.
Regulatory Problem
Signal detection software, safety databases, and EDMS platforms used in pharmacovigilance must be 21 CFR Part 11 compliant and validated to withstand EMA, MHRA, and FDA audits. System changes, upgrades, and new implementations without documented validation protocols create immediate audit exposure and can invalidate safety data submitted to regulators.
Our Methodology
Full CSV (Computer System Validation) lifecycle delivery: URS authoring, risk-based validation planning, IQ/OQ/PQ protocol execution, and validation summary reports. 21 CFR Part 11 gap assessments for existing systems. Change control documentation for upgrades. Ongoing periodic review scheduling to maintain validated status.
Validated Platforms
Process Workflow
PV Lifecycle