Regulatory, Tech Transfer & Support Services
Company Overview
About
o9 Solutions, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2009
Employees:2,233
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
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval Z1NTOM
EMA · #APR-5T0WO3KX · 2019-08-01
Drug Approval R7QGG4
FDA · #APR-MO8BDLGV · 2022-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-N25UIKL2
Issued: 2020-05-12
Expires: 2025-03-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-IJ39JY1Z
Issued: 2020-08-14
Expires: 2025-07-21
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-0MKP3X6S
Issued: 2020-01-15
Expires: 2025-09-16
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Key facts about o9 Solutions, Inc.
- o9 Solutions, Inc. is headquartered in the United States.
- o9 Solutions, Inc. was founded in 2009.
- o9 Solutions, Inc. has 2,233 employees.
- o9 Solutions, Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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