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


  • 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