Drug Product
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
PCI Pharma Services is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Australia
Founded:2000
Employees:1,257
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
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 KIKCLU
PMDA · #APR-18B5ZIFI · 2018-02-01
Drug Approval I8EMO9
PMDA · #APR-J7LCMN0I · 2020-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-RRPNVMBM
Issued: 2020-01-22
Expires: 2025-12-27
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-LYQVHVG7
Issued: 2020-04-23
Expires: 2025-11-07
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-ZS87ORI0
Issued: 2020-01-10
Expires: 2025-09-06
Loading CDMO intelligence...
Key facts about PCI Pharma Services
- PCI Pharma Services is headquartered in Australia.
- PCI Pharma Services was founded in 2000.
- PCI Pharma Services has 1,257 employees.
- PCI Pharma Services's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
Find CDMOs like PCI Pharma Services
Directory pages this company appears in, each with the full list of matching manufacturers.