Development

Full-service Development: development,validation, transfer, stability

 

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Unither Développement Bordeaux (UDB) is Unither Pharmaceuticals group’s Innovation & Development center. For more than 30 years, we are working with a panel of customers, researchers, physicians, scientists, pharmacists, from public institutions, start-ups, and small, medium and big pharmaceutical companies. Our scientific and technical expertise allow us to manage Pharmaceutical Development combining Galenic Formulation and Analytical Support starting from early stages developments, clinical trial phases, to commercial manufacturing. UDB is the ideal partner to support the manufacturing of small batches for Clinical Trials and Orphan Drugs.

 

 

Our way of thinking and working

Highly skilled multi-specialty project managers dedicated to clients’ R&D to commercial programs

  • Development strategy focused on risk management and quality, using QbD (Quality by Design) approach
  • Secure, cost efficient solutions using Design of Experiments (DOE)
  • Highly qualified multi-disciplinary technical team
  • Advanced, efficient, cost-effective process and analytical tools

 

 

Galenic development

Specializing in contract manufacturing, Unither ensures that its innovative galenic forms remain competitive, practical and easy to use for the patients. The development of those galenic formulations for pharmaceutical use aims to improve the lives of patients and doctors. Unither focuses on the development and manufacture of quality single-dose drugs using Blow-Fill-Seal (BFS), Preservative-free multidose (PFMD) and liquid stick-packs technologies.

Ideal for active patients' lifestyles, unit doses are dosage forms that are both easy to carry and administer as treatment products, thus significantly improving not only dosage accuracy but also patient compliance and treatment experience.

 

Primary packaging

  • Blow-fill-seal single-doses (BFS) and multidoses
  • Liquid stick-packs
  • Bottles and vials
  • Spray
  • Blisters (PVC/ALU, PVC-PVDC/ALU, ALU/ALU, Aclar, Triplex)
    Pill boxes
  • Flexible HDPE tubes, aluminum tubes for topicals

 

Analytical development

 

Analytical testing constantly assesses the product quality from development to final release.

Our team comprises analytical experts using regularly maintained, updated, and qualified equipment to perform the following services:

  • Analytical Methods Development and Validation
  • Analytical Methods Transfer
  • Storage in ICH and stability testing
  • Extractables / Leachables risk analysis
  • ICHQ3D guideline risk analysis
  • Nitrosamine risk analysis
  • Cleaning validation

Manufacturing

Innovation

Co-Development