Your entire safety database,
answering back.
Catalyst reads adverse event reports, cross-references drug interaction databases, and answers medical affairs queries in seconds — with cited sources and full audit trails.
< 4s
Avg. query response
99.2%
ICSR compliance score
14K+
ICSRs processed / pilot
Why teams switch
to Catalyst.
Query Response Time
Time from question input to cited answer
Citation Accuracy
Source document references verified correct
Regulatory Template Coverage
ICH E2B(R3), PBRER, DSUR, CIOMS I–VIII
ICSR Processing Volume
Cases processed per 24-hour period
GxP Audit Trail
Immutable query log with user attribution
Drug Interaction Cross-Reference
Live cross-reference against interaction databases
Signal Detection (EBGM)
Automated disproportionality analysis
* Benchmark data based on independent validation study, n=4 mid-size pharmaceutical companies, Q4 2025. Full methodology available on request.
14,204 ICSRs.
72 hours. 99.2% compliant.
A mid-size oncology company processed their entire annual ICSR backlog over a single weekend — without adding headcount, without extending deadlines.
ICSRs Processed
0
of 14,204 total
Compliance Score
99.2%
ICH E2B(R3) standard
Final compliance check passed — ready for regulatory submission
340+
FTE hours saved
98.3%
MedDRA match rate
Yes
Submission ready
Built for regulated environments.
Auditable by design.
Catalyst was purpose-built for pharmaceutical compliance — every query logged, every source cited, every output traceable to its regulatory basis.
SOC 2 Type II
Security & Availability
Annual audit by Deloitte
HIPAA Compliant
PHI Data Handling
BAA available on request
21 CFR Part 11
Electronic Records
FDA-compliant audit trails
ICH E6(R3)
GCP Guidelines
GCP-aligned data handling
ISO 27001
Information Security
Certified infrastructure
GDPR Article 25
Privacy by Design
EU data residency options
Catalyst demonstrated 99.1% citation accuracy across 2,400 randomly sampled PSUR queries, outperforming manual review (91.4%) and the leading NLP comparator (87.2%). Query response latency averaged 3.8 seconds. GxP audit trail completeness was rated "fully compliant" with 21 CFR Part 11 requirements.
PharmaTech Consulting Group
Independent Validation Study, Q4 2025
Citation accuracy
99.1%
+7.7% vs manual
Avg. response time
3.8s
50× faster than manual
Audit completeness
100%
21 CFR Part 11
Medical Science Liaison
Answer HCP questions at congress in real time — with cited literature, not memory.
Pharmacovigilance Analyst
Clear ICSR backlogs before submission deadlines without weekend overtime.
Regulatory Affairs Manager
Receive a compliant first draft before the senior reviewer opens the document.
Run a pilot on
your actual data.
We configure Catalyst against your ICSR database, PSUR archive, and regulatory templates. You run queries. You see results. No migration, no long-term commitment — just answers.
Configured to your therapeutic area and MedDRA version
Connected to your existing E2B(R3) data source
Full GxP audit trail from day one
2-week pilot with dedicated PV specialist support
Not ready to pilot yet?
Download the full benchmark methodology and validation study.
Catalyst — 99.2% ICSR compliance. 3.8s query response. GxP auditable.