Located in Bordeaux,within an innovation and healthcare cluster, Unither development has proven its expertise in the following areas:

Formulation development

• Pre-formulae survey (new active ingredients)
• Formulation
• Industrial transposition / process validation

A team of galenists helped by a pharmacist and an engineer put together around 20 formulas per year among the following pharmaceutical presentations: tablets, coated tablets, effervescent tablets, soft gel, sachets, syrups, aqueous solutions, creams, pomades and gel. The dry forms can be developed with a modified release profile

Analytical development

• Set up and validation of the analysis method
• Storage in air controlled rooms according to ICH conditions
• Stability survey
• Dissolution survey
• Quality control

Production and packaging

• Pilot batches
• Clinical batches
• Batches for stability testing
• Orphan drugs

Stability testing

• On-going stabilities
• Stabilities for clinical trials

Quality control (audit and release)

Drafting of CTD & IMPD section 3

As part of an industrial group, Unither Development provides its clients with 2 main advantages::

• Integration of industrial constraints during product development in order to optimize manufacturing costs
• Full-service project development, from the formulation to the industrial manufacture.