Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
TraceLink is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2019
Employees:834
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval M4980Y
EMA · #APR-3BEKIYYE · 2018-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-P6W44M0X
Issued: 2020-02-12
Expires: 2025-09-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-RMR9LO47
Issued: 2020-02-01
Expires: 2025-07-23
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Key facts about TraceLink
- TraceLink is headquartered in the United States.
- TraceLink was founded in 2019.
- TraceLink has 834 employees.
- TraceLink's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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