RoslinCT

Edinburgh, UK · Hopkinton, MA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
80.2
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (1)

Quick Facts: RoslinCT

Signal Score
80.2/100 (as of 2026-04-02)
Quality Compliance
98.8/100
Headquarters
Edinburgh, UK · Hopkinton, MA
Modalities
CAR-T, Cell Therapy, iPSC, Gene Editing
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

Signal Score & Pillar Breakdown

Quality Compliance 98.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-01-21)
MHRA GMP Certificates1 on record
Operations
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs no verified data
Sponsorsno verified data
ModalitiesCAR-T, Cell Therapy, iPSC, Gene Editing
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 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 68.0
2 manufacturing sites
Broad modality coverage (4 modalities)
Sites: Edinburgh, UK, Hopkinton, MA
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusAvailable
2 manufacturing sites
Broad modality coverage (4 modalities)
Sites: Edinburgh, UK, Hopkinton, MA
2 manufacturing sites
Broad modality coverage (4 modalities)

FDA Inspection History

2025-01
NAI VAI OAI
Date Site Type Observations Classification
2025-01-21 Edinburgh Human Cellular, Tissue, and Gene Therapies Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

MHRA GMP Compliance 1 certificates

2021-07
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA(IMP) 45803 Insp IMP 45803/4883575-0018[I] ROSLINCT INSTITUTE FOR REGENERATION AND REPAIR NORTH EDINBURGH EH16 4UU 2021-07-27 COMPLIANT
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
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