Regis Custom Pharma (Regis Technologies, Inc.)
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Drug Product
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
Regis Custom Pharma (Regis Technologies, Inc.) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United States
Founded:2005
Employees:2,163
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
Esteve CDMO US, Inc. dba Regis Chemical Company
8210 Austin Avenue, Morton Grove, Illinois, 60053
Site Capabilities
2 capabilitiesAPI MANUFACTURE
MANUFACTURE
Regulatory Approvals
Drug Approval N77E2W
EMA · #APR-YPEMP55G · 2022-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-CK6HQJK5
Issued: 2020-04-08
Expires: 2025-04-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-EX8S2PD7
Issued: 2020-09-21
Expires: 2025-02-06
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-78423VIB
Issued: 2020-02-08
Expires: 2025-09-06
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-8K7GQMLQ
Issued: 2020-08-18
Expires: 2025-04-21
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Key facts about Regis Custom Pharma (Regis Technologies, Inc.)
- Regis Custom Pharma (Regis Technologies, Inc.) is headquartered in the United States.
- Regis Custom Pharma (Regis Technologies, Inc.) was founded in 2005.
- Regis Custom Pharma (Regis Technologies, Inc.) has 2,163 employees.
- Regis Custom Pharma (Regis Technologies, Inc.) has one manufacturing site listed on CDMO Hub, in Morton Grove, United States.
- Regis Custom Pharma (Regis Technologies, Inc.)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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