Good Biomarker Sciences (GBS Leiden)
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Analytical & Bioanalytical Services
Contract Research Organization
Company Overview
About
Good Biomarker Sciences (GBS Leiden) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:Netherlands
Founded:2014
Employees:2,592
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval 553A18
EMA · #APR-G6RF2GQY · 2022-04-01
Drug Approval NO9FVB
FDA · #APR-RWJXNDD2 · 2022-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-8DSZ105R
Issued: 2020-03-18
Expires: 2025-02-19
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-GG05S1PB
Issued: 2020-11-17
Expires: 2025-09-01
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-VBINX83P
Issued: 2020-03-07
Expires: 2025-09-10
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Key facts about Good Biomarker Sciences (GBS Leiden)
- Good Biomarker Sciences (GBS Leiden) is headquartered in the Netherlands.
- Good Biomarker Sciences (GBS Leiden) was founded in 2014.
- Good Biomarker Sciences (GBS Leiden) has 2,592 employees.
- Good Biomarker Sciences (GBS Leiden)'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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