Biovian
Turku, Finland
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
78.0
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (4)
○ MHRA GMP
Quick Facts: Biovian
- Signal Score
- 78.0/100 (as of 2026-09-07)
- Quality Compliance
- 99.8/100
- Headquarters
- Turku, Finland
- Modalities
- AAV, Lentiviral
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Biovian
Pure-play CDMO.
Signal Score & Pillar Breakdown
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
99.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2024-12-19)
EMA GMP Certificates4 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
58.0
Profile-based capacity assessment
Biovian FDA Inspection History
2024-12
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-12-19 |
Biovian Oy
Turku
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 06, 2026
Biovian EMA GMP Compliance 4 certificates
2026-03
2024-12
2024-12
2024-12
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| FIMEA/2026/001005 laboratory | Biovian Oy | Finland | 2026-03-18 | COMPLIANT |
| FIMEA/2024/006346 laboratory | Biovian Oy | Finland | 2024-12-19 | COMPLIANT |
| FIMEA/2024/006346 IMP | Biovian Oy | Finland | 2024-12-19 | COMPLIANT |
| FIMEA/2024/006346 | Biovian Oy | Finland | 2024-12-19 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 06, 2026
Frequently Asked Questions About Biovian
How many FDA inspections does Biovian have on record?
CDMO Signal tracks 1 FDA inspection for Biovian, sourced from the FDA inspection database. See the full inspection history above.
Has Biovian received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Biovian.
Does Biovian hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Biovian.
What is Biovian's CDMO Signal Score?
Biovian has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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