Contract Research Organization
Regulatory, Tech Transfer & Support Services
Company Overview
About
FGK Clinical Research is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Czechia
Founded:1999
Employees:2,233
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Regulatory Approvals
Drug Approval 3AKF4I
Health Canada · #APR-CN3BQK5I · 2018-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-D7Y2PH4S
Issued: 2020-10-25
Expires: 2025-07-01
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-H8H7H0G6
Issued: 2020-06-23
Expires: 2025-02-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-8Y4UP8AC
Issued: 2020-01-28
Expires: 2025-07-25
WHO GMP
World Health Organization
Cert #: CERT-UJTRYP99
Issued: 2020-06-23
Expires: 2025-08-20
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Key facts about FGK Clinical Research
- FGK Clinical Research is headquartered in Czechia.
- FGK Clinical Research was founded in 1999.
- FGK Clinical Research has 2,233 employees.
- FGK Clinical Research's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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