Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
PiLeje Industrie is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:France
Founded:2018
Employees:1,507
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval R7CSYI
Health Canada · #APR-UV89VY07 · 2018-06-01
Drug Approval S2YVCS
FDA · #APR-SFY8SC12 · 2021-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-Y4S4Z3Z8
Issued: 2020-02-18
Expires: 2025-04-15
Health Canada GMP
Health Canada
Cert #: CERT-X7NI333I
Issued: 2020-05-23
Expires: 2025-11-28
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Key facts about PiLeje Industrie
- PiLeje Industrie is headquartered in France.
- PiLeje Industrie was founded in 2018.
- PiLeje Industrie has 1,507 employees.
- PiLeje Industrie's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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