BioReliance (Merck)
Glasgow, UK · Rockville, MD
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
78.2
Signal Score
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (8)
Quick Facts: BioReliance (Merck)
- Signal Score
- 78.2/100 (as of 2026-04-29)
- Quality Compliance
- 92.7/100
- Headquarters
- Glasgow, UK · Rockville, MD
- Modalities
- AAV, Lentiviral, Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- 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
Quality Compliance
92.7
FDA Inspections3 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-01-29)
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
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Parent company: Merck KGaA
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Merck KGaA
Financial assessment: 68.0/100
Capacity
63.0
2 manufacturing sites
Sites: Glasgow, UK, Rockville, MD
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
2 manufacturing sites
BioReliance (Merck) FDA Inspection History
2026-01
2025-12
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-01-29 | Rockville, Maryland | Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-12-05 | Glasgow | Vaccines and Allergenic Products | No | Voluntary Action Indicated (VAI) |
| 2024-11-22 | Rockville, Maryland | Vaccines and Allergenic Products | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 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 Jul 04, 2026
Frequently Asked Questions About BioReliance (Merck)
How many FDA inspections does BioReliance (Merck) have on record?
CDMO Signal tracks 3 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 78/100, based on quality, operations, financial stability, and capacity data.
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