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Quality
Quality assurance
Unither Développement Bordeaux offers clients strength in quality assurance based on expertise within a team of Ph.D. scientists, compliance with global regulatory standards, and robust practices for procedural systems.
- European GMP-approved facility for importation, manufacture, control and certification of clinical and commercial batches (ANSM / ANSES)
- Shelf life confirmation for clinical batches
- EMA, FDA and ICH-regulatory compliant service
- Documentation management according to ICH Q10)
- Analytical and manufacturing activities compliant with GMP procedures
- Regular internal and external audits
- Comprehensive contractual agreements with suppliers and subcontractors
- Contracts for pharmaceutical, consumer health, veterinary, cosmetic, hormone, sulfamide and narcotics supplies and services
Benefits
- Flexible, globally oriented structure
- GMP quality continuous improvement programs
- Laboratory with excellent reputation and customer satisfaction rating*
Authorizations & Certifications
ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)
- Manufacture and control of medicine for human use.
- Manufacture of medicine for clinical trials (human)
- Export / import to other countries
- Hormones / Sulfamid / Narcotic drugs
- Cosmetics
ANSES (Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail)
- Manufacture and control of medicine for animal use
- Manufacture of medicine for clinical trials (animal)
MNCPC (Mission Nationale de Contrôle des Précurseurs Chimiques)
Import / purchase / storage / transportation of precursor drugs
CIR (Crédit Impôt Recherche du Ministère de l’Enseignement Supérieur et de la Recherche) French tax credit / refund