Advanced Modalities
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
Scinai Immunotherapeutics is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Israel
Founded:1994
Employees:199
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval TJ0572
FDA · #APR-NQSJKG5Y · 2022-07-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-CGML0B3W
Issued: 2020-10-18
Expires: 2025-03-18
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-VPBNH0JV
Issued: 2020-09-06
Expires: 2025-12-25
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-W7GWTAS8
Issued: 2020-10-04
Expires: 2025-05-27
Health Canada GMP
Health Canada
Cert #: CERT-SDGK4EHQ
Issued: 2020-12-01
Expires: 2025-06-16
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Key facts about Scinai Immunotherapeutics
- Scinai Immunotherapeutics is headquartered in Israel.
- Scinai Immunotherapeutics was founded in 1994.
- Scinai Immunotherapeutics has 199 employees.
- Scinai Immunotherapeutics's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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