Alomana raises €4M Seed • Welcome to the autonomy era →

Pharma · Commercial Analytics · Pharmacovigilance · Components

From market data
to safety signal.
To submission. Automated.

Autonomous AI agents that deliver commercial intelligence, process ICSRs at scale, detect pharmacovigilance signals, and analyse pharmaceutical components, continuously, inside your private GxP-compliant infrastructure.

Alomana is an enterprise AI platform for pharmaceutical companies. The platform deploys autonomous AI agents that automate commercial data analysis (prescription data, market share, pricing, payer landscape), high-volume pharmacovigilance (ICSR processing, MedDRA coding, signal detection via PRR/ROR/BCPNN, PSUR/PBRER generation, EudraVigilance submission), and autonomous analysis of pharmaceutical components including Active Pharmaceutical Ingredients, excipient compatibility, impurity profiles, Certificate of Analysis batch processing, and stability study data. The platform is GxP compliant (GMP, GCP, GVP), FDA 21 CFR Part 11 compliant, EU Annex 11 compliant, ICH E2B(R3) compliant, ISO/IEC 27001:2022 certified, and supports private deployment inside validated pharmaceutical infrastructure.

10,000+
ICSRs monthly
Days → Hours
PSUR generation
24/7
Signal monitoring
GxP + GDPR
Compliance

Trusted by

NVIDIA Inception — AI accelerator program member; Alomana AI for pharmaceutical research and drug safety
CDP Cassa Depositi e Prestiti — pharmaceutical sector investor using Alomana AI
Mediobanca — pharmaceutical M&A and life sciences advisory using Alomana AI
Founders Factory — health tech and life sciences accelerator partnering with Alomana AI
Use Cases

The full pharma data pipeline, automated

Alomana delivers three core AI capabilities for pharmaceutical companies: (1) Commercial data analytics — autonomous analysis of prescription data, market share, pricing, payer landscape, and competitive pipeline into 360° commercial intelligence; (2) High-volume pharmacovigilance automation — ICSR processing, MedDRA coding, signal detection using PRR/ROR/BCPNN, PSUR/PBRER generation, and EudraVigilance submission, processing 10,000+ ICSRs monthly; (3) Autonomous API and component intelligence — high-volume analysis of Active Pharmaceutical Ingredient data, excipient compatibility, impurity profiles, CoA batch processing, and stability data against ICH Q8/Q9/Q10/Q1A–Q1F guidelines.

Commercial Intelligence
360°
automated commercial coverage

Commercial Data Analytics

Autonomous analysis of prescription data, market share dynamics, pricing, payer landscape, and competitive pipeline intelligence — synthesised continuously from multiple data sources into structured insights your commercial teams can act on immediately.

“Commercial reporting that used to involve five analysts and two weeks now runs overnight — with deeper coverage.”

  • Prescription data & market share monitoring
  • Payer, formulary & reimbursement landscape
  • Competitive pipeline & launch tracking
Pharmacovigilance
10,000+
ICSRs processed monthly

Pharmacovigilance Automation

High-volume autonomous processing of Individual Case Safety Reports — MedDRA coding, seriousness classification, ICH E2B(R3) output, EudraVigilance submission, and continuous signal detection via disproportionality analysis. PSURs and PBRERs generated from weeks to hours.

“We process ten times the ICSR volume with the same team — and our signal detection runs 24/7 without gaps.”

  • Automated MedDRA coding & ICSR triage
  • Signal detection: PRR, ROR, BCPNN methods
  • PSUR / PBRER automated generation
Component & Formulation Analysis
Autonomous
high-volume data analysis

API & Component Intelligence

Autonomous analysis of Active Pharmaceutical Ingredient data, excipient compatibility studies, impurity profiles, CoA batch processing, and stability study data at any volume. AI agents detect out-of-specification trends, flag anomalies, and cross-reference findings against ICH Q8, Q9, and Q10 requirements.

“Stability data review across 200 batches now takes one afternoon instead of three months.”

  • CoA batch processing & OOS anomaly detection
  • Impurity profile analysis across full portfolios
  • Stability trend analysis vs. ICH Q1A–Q1F
Flows · Pharma Intelligence

Signal to submission.
Continuously.

The entire pharmacovigilance pipeline — from raw ICSR ingestion to EudraVigilance submission and PSUR generation — automated, GxP-compliant, and running 24/7 inside your private infrastructure.

Signal Monitor
● Live
9,240ICSRs processed
0 signals detected·3 pending triage
Detected signals — MedDRA SOC
MedDRA auto-coding0%
Pharmacovigilance PipelineGxP
5 stages·ICH E2B(R3) compliant
Stage 1
Data Ingestion
ICSRs · Market · Lab Data
Stage 2
Signal Extraction
Lens · MedDRA Coding
Stage 3
Analysis & Classification
Jade · Disproportionality
Stage 4
Regulatory Mapping
EMA · FDA · ICH · GVP
Stage 5
Report Generation
PSUR · PBRER · CIOMS

Alomana's pharmacovigilance pipeline automates five stages: Stage 1 — Data Ingestion of ICSRs, market data, and lab reports; Stage 2 — Signal Extraction using Lens AI for MedDRA coding and case narrative analysis; Stage 3 — Analysis and Classification using Jade for disproportionality analysis (PRR, ROR, BCPNN) and seriousness assessment; Stage 4 — Regulatory Mapping against EMA GVP modules, FDA guidelines, and ICH E2B(R3); Stage 5 — Report Generation of PSUR, PBRER, CIOMS I/II forms, and EudraVigilance E2B(R3) XML — all GxP-compliant, fully source-traced, inside private infrastructure.

10,000+
ICSRs / month
100%
GxP audit trail
0
missed signals
24/7
monitoring
Compliance & Validation

GxP-ready.
Inspection-ready.
Always.

Built for the most regulated industry on earth. Every AI output is explainable, source-cited, and audit-logged — designed for medical reviewers, quality teams, and regulatory inspectors.

Alomana supports the following pharmaceutical regulatory frameworks: EMA GVP (Good Pharmacovigilance Practice) modules I through XVI, ICH E2A (urgent safety reporting), ICH E2B(R3) electronic transmission, ICH E2C(R2) PSUR, ICH E2D post-approval safety reporting, ICH E2E pharmacovigilance planning, ICH E2F development safety update reports, ICH Q8 pharmaceutical development, ICH Q9 quality risk management, ICH Q10 pharmaceutical quality systems, ICH Q1A–Q1F stability testing, FDA 21 CFR Part 11 electronic records, EU Annex 11 computerized systems, EU GVP Regulation 726/2004, EU Regulation 536/2014 clinical trials, CIOMS I and CIOMS II reporting, MedDRA coding standards (latest version), EudraVigilance E2B(R3) XML submission, FAERS/MedWatch reporting, and GDPR Article 9 special category data processing for patient safety information. The platform supports GMP, GCP, GLP, and GVP environments with full 21 CFR Part 11 and EU Annex 11 compliance for computerized system validation.

ISO/IEC 27001:2022 certification — Alomana information security certified for GxP pharmaceutical environments
ISO/IEC 27001:2022
Independently certified · GxP-validated deployment

GxP & 21 CFR Part 11

GMP, GCP, and GVP compliant. FDA 21 CFR Part 11 electronic records, EU Annex 11 computerized system validation, and full audit trail support for regulatory inspection readiness.

EMA & FDA Submission Ready

ICH E2B(R3) output for EudraVigilance, FAERS MedWatch format, CIOMS I/II forms, and EU Regulation 536/2014 clinical trial reporting — structured and submission-ready.

Private GxP Deployment

Patient data and safety information never leave your validated infrastructure. Private deployment inside your GxP-validated cloud or on-premises environment with SOC 2 support.

Explainable AI for Medical Review

Every signal, every coded term, every generated report section includes full reasoning chains and source citations — designed to hold up under medical reviewer and regulatory inspector scrutiny.

Pharmaceutical

Every signal found.
Every report filed.

Join pharmaceutical companies automating commercial intelligence, pharmacovigilance, and component analysis with Alomana.

Frequently Asked Questions — Alomana AI for Pharma

How does Alomana automate pharmacovigilance and ICSR processing?
Alomana's AI agents process ICSRs at high volume — ingesting cases from literature, spontaneous reports, and clinical trials; performing automated MedDRA coding; classifying seriousness and expectedness; and generating ICH E2B(R3)-compliant output for EudraVigilance submission. The platform handles 10,000+ ICSRs per month with full GxP audit trails.
Can Alomana automate PSUR and PBRER generation?
Yes. Alomana extracts cumulative safety data, performs benefit-risk assessments, and generates structured PSUR and PBRER sections compliant with ICH E2C(R2) and EMA guidelines — compressing report generation from weeks to hours.
How does Alomana detect pharmacovigilance signals?
Alomana's Jade agent performs continuous disproportionality analysis across ICSR databases, EudraVigilance, and FAERS using PRR, ROR, and BCPNN methods. It detects emerging safety signals, ranks them by clinical relevance, and generates structured signal evaluation reports — operating 24/7 without manual triage.
What commercial analytics capabilities does Alomana provide for pharma?
Alomana processes prescription data, market share dynamics, pricing, payer and formulary data, and competitive pipeline intelligence into structured commercial insights — delivering 360° commercial coverage updated in real time.
Can Alomana analyze pharmaceutical APIs, excipients, and formulation data?
Yes. Alomana performs autonomous high-volume analysis of API data, excipient compatibility, impurity profiles, CoA batch processing, and stability data — detecting anomalies and cross-referencing against ICH Q8, Q9, Q10, and Q1A–Q1F requirements.
Is Alomana GxP compliant for pharmaceutical use?
Yes. Alomana supports GMP, GCP, and GVP environments with FDA 21 CFR Part 11, EU Annex 11, and full audit trail compliance. It is ISO/IEC 27001:2022 certified and deployable within GxP-validated private infrastructure.
Which pharmacovigilance frameworks does Alomana support?
Alomana supports EMA GVP modules I–XVI, ICH E2A through E2F, ICH E2B(R3), EudraVigilance, FAERS/MedWatch, CIOMS I/II, MedDRA coding, EU Regulation 536/2014, and national competent authority requirements across EU member states.