Regulatory, Tech Transfer & Support Services
Company Overview
About
Blue Yonder is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2018
Employees:627
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
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 2N550L
FDA · #APR-RYWC65JC · 2022-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-U2LDJ3QW
Issued: 2020-02-15
Expires: 2025-04-03
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-5W2UK9ED
Issued: 2020-05-09
Expires: 2025-12-27
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4EM6Z71J
Issued: 2020-07-13
Expires: 2025-07-28
Health Canada GMP
Health Canada
Cert #: CERT-S1NMYPFT
Issued: 2020-04-06
Expires: 2025-03-26
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Key facts about Blue Yonder
- Blue Yonder is headquartered in the United States.
- Blue Yonder was founded in 2018.
- Blue Yonder has 627 employees.
- Blue Yonder's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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