Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
EditCo Bio is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:1997
Employees:618
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
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 1XKVIV
EMA · #APR-RSGCP08M · 2019-04-01
Drug Approval 0VFGPW
PMDA · #APR-RWMRRBTY · 2018-03-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-7675XRIV
Issued: 2020-07-06
Expires: 2025-10-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-HXRTDQPO
Issued: 2020-10-24
Expires: 2025-10-08
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-SMBA4LQE
Issued: 2020-05-19
Expires: 2025-03-05
Health Canada GMP
Health Canada
Cert #: CERT-NS8T5GTV
Issued: 2020-05-02
Expires: 2025-03-23
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Key facts about EditCo Bio
- EditCo Bio is headquartered in the United States.
- EditCo Bio was founded in 1997.
- EditCo Bio has 618 employees.
- EditCo Bio's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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