Analytical & Bioanalytical Services
Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
PSC Biotech 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:2009
Employees:1,617
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval Y8C317
Health Canada · #APR-4W2GDAZK · 2019-09-01
Drug Approval EECWNM
PMDA · #APR-5YA004E2 · 2022-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-8Q1C5BKB
Issued: 2020-09-17
Expires: 2025-09-09
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GBYXH9T9
Issued: 2020-08-15
Expires: 2025-06-20
Health Canada GMP
Health Canada
Cert #: CERT-EZTHHSWY
Issued: 2020-08-09
Expires: 2025-07-18
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Key facts about PSC Biotech
- PSC Biotech is headquartered in the United States.
- PSC Biotech was founded in 2009.
- PSC Biotech has 1,617 employees.
- PSC Biotech's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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