Analytical & Bioanalytical Services
Contract Research Organization
Company Overview
About
BioIVT is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United Kingdom
Founded:2015
Employees:1,097
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Regulatory Approvals
Drug Approval VP2S08
FDA · #APR-NYDT224V · 2019-11-01
Drug Approval U959RX
EMA · #APR-PZCOV0R7 · 2020-02-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-XNSRJOW4
Issued: 2020-11-22
Expires: 2025-06-06
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-4W8J00MM
Issued: 2020-11-05
Expires: 2025-11-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-64IJE3XJ
Issued: 2020-05-03
Expires: 2025-10-25
WHO GMP
World Health Organization
Cert #: CERT-NMTUMM65
Issued: 2020-07-19
Expires: 2025-10-12
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Key facts about BioIVT
- BioIVT is headquartered in the United Kingdom.
- BioIVT was founded in 2015.
- BioIVT has 1,097 employees.
- BioIVT's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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