Cebiphar
Analytical CRO founded in 1979 providing analytical, microbiological, preclinical and regulatory support for human and veterinary health product development. Offers analytical method development/validation/transfer, stability testing (ICH/VICH), quality-control testing, microbiology services, veterinary preclinical and field clinical studies, cleaning validation and technical-regulatory dossier support. Operates sites in France with GLP/GCP/BPL/BPF/cGMP regulatory experience and audited partnerships for specialized analyses.
Industries
Nr. of Employees
medium (51-250)
Cebiphar
Services
QC testing of raw materials, packaging and finished products; monograph development; residual solvents testing; re-control and release of imported lots.
Method development using AQbD principles, validation per ICH/USP guidance and documented transfers to receiving sites with training and support.
Comprehensive stability programs (long-term, accelerated, intermediate), forced degradation and transport simulation with secure sample storage.
Design and execution of cleaning validation strategies, sampling technique validation, recovery studies and cleaning documentation.
Antibiotic titration, MIC/MBC determination, bactericidal kinetics, validation of microbiological methods and maintenance of strain collections.
Analytical investigations for OOS, stability anomalies, chromatographic changes and expert reports to support IP or legal actions.
QC testing of raw materials, packaging and finished products; monograph development; residual solvents testing; re-control and release of imported lots.
Method development using AQbD principles, validation per ICH/USP guidance and documented transfers to receiving sites with training and support.
Comprehensive stability programs (long-term, accelerated, intermediate), forced degradation and transport simulation with secure sample storage.
Design and execution of cleaning validation strategies, sampling technique validation, recovery studies and cleaning documentation.
Antibiotic titration, MIC/MBC determination, bactericidal kinetics, validation of microbiological methods and maintenance of strain collections.
Analytical investigations for OOS, stability anomalies, chromatographic changes and expert reports to support IP or legal actions.
Expertise Areas
- Analytical method lifecycle management
- Pharmaceutical quality control testing
- Stability testing (ICH/VICH)
- Microbiology and antimicrobial susceptibility testing
Key Technologies
- HPLC / UHPLC (UV, DAD, RI, fluorescence, MS)
- GC (FID, MS, headspace)
- LC-MS
- Dissolution testing (online/offline)
News & Updates
Company teams attending sector conferences to present expertise and meet partners (Sept–Oct 2024 events listed).
Announcement of increased sample storage and stability capabilities at the Fondettes site.
Renewed agrément allowing R&D prestations to be eligible for Crédit d'Impôt Recherche.
Company teams attending sector conferences to present expertise and meet partners (Sept–Oct 2024 events listed).
Announcement of increased sample storage and stability capabilities at the Fondettes site.
Renewed agrément allowing R&D prestations to be eligible for Crédit d'Impôt Recherche.