BioReliance (Merck)
Glasgow, UK · Rockville, MD
Hybrid — also manufactures internal programs
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
80.2
Signal Score
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (8)
Quick Facts: BioReliance (Merck)
- Signal Score
- 80.2/100 (as of 2026-09-07)
- Quality Compliance
- 97.1/100
- Headquarters
- Glasgow, UK · Rockville, MD
- Modalities
- AAV, Lentiviral, Biologics
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About BioReliance (Merck)
Hybrid developer + 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
97.1
FDA Inspections4 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-05-13)
MHRA GMP Certificates8 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral, Biologics
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
63.0
Profile-based capacity assessment
BioReliance (Merck) FDA Inspection History
2026-05
2026-01
2025-12
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-05-13 |
Bioreliance Ltd.
Glasgow
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2026-01-29 |
BioReliance Corporation
Rockville, Maryland
Facility-linked
|
Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-12-05 |
Bioreliance Ltd.
Glasgow
Facility-linked
|
Vaccines and Allergenic Products | No | Voluntary Action Indicated (VAI) |
| 2024-11-22 |
BioReliance Corporation
Rockville, Maryland
Facility-linked
|
Vaccines and Allergenic Products | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 06, 2026
BioReliance (Merck) FDA 483 Findings 2 observations · 2026-01-29 → 2026-01-29 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 1
- Repeat observations: 0
Most severe findings
-
Study director: unforeseen circumstances
"The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented."
-
Study director: follow study protocol
"The study director failed to assure that the protocol, including any change, was approved and was followed."
BioReliance (Merck) MHRA GMP Compliance 8 certificates
2025-05
2025-05
2025-03
2025-03
2025-02
2025-02
2013-07
2012-07
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 22774 Insp GMP/IMP 22774/31007-0023 [H] | BIORELIANCE LIMITED | STIRLING FK9 4NF | 2025-05-02 | COMPLIANT |
| UK GMP 22774 Insp GMP/IMP 22774/31007-0023 [V] | BIORELIANCE LIMITED | STIRLING FK9 4NF | 2025-05-02 | COMPLIANT |
| UK GMP 22774 Insp GMP/IMP 22774/2062763-0012 [H] | BIORELIANCE LIMITED | PENICUIK EH26 0PZ | 2025-03-19 | COMPLIANT |
| UK GMP 22774 Insp GMP/IMP 22774/2062763-0012 [V] | BIORELIANCE LIMITED | PENICUIK EH26 0PZ | 2025-03-19 | COMPLIANT |
| UK MIA 22774 Insp GMP 13987/4473-0031[H] | BIORELIANCE LIMITED | GLASGOW G20 0XA | 2025-02-13 | COMPLIANT |
| UK API 22774 Insp GMP 13987/4473-0031 | BIORELIANCE LIMITED | GLASGOW G20 0XA | 2025-02-13 | COMPLIANT |
| UK GMP 18729 Insp GMP 18729/376405-0002[H] | BIORELIANCE CORPORATION | 20850-3349 | 2013-07-15 | COMPLIANT |
| UK MIA 22774 Insp GMP/IMP 22774/31007-0012[H] | BIORELIANCE LIMITED | STIRLING FK9 4NF | 2012-07-25 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Oct 06, 2026
Frequently Asked Questions About BioReliance (Merck)
How many FDA inspections does BioReliance (Merck) have on record?
CDMO Signal tracks 4 FDA inspections for BioReliance (Merck), sourced from the FDA inspection database. See the full inspection history above.
Has BioReliance (Merck) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for BioReliance (Merck).
Does BioReliance (Merck) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 8 MHRA GMP certificates for BioReliance (Merck).
What is BioReliance (Merck)'s CDMO Signal Score?
BioReliance (Merck) has a Signal Score of 80/100, based on quality, operations, financial stability, and capacity data.
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