Development supports  

The units of pre-clinical and clinical development use the following services : the chemistry, the analysis, the galenical, clinical trials, the service of biometry and of data processing, regulatory affairs and the "clinical supply". The objective of the unit consists of presenting in the best conditions, that is to say with all the guarantees of therapeutic efficiency and of security, the products to the registration authorities to grant the authorizations of marketing.

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Development unit for processes This unit consists of a laboratory of optimization of processes, assigned to research industrial processes, the determination of the ways of synthesis, studies of robustness. This laboratory elaborates the set of procedures or of projects of industrialisable techniques. This service includes in addition a pilot workshop of development of processes before a preparation activity of batches for clinical study·
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Analytic Service.  

This service must undertake the research demonstrating the chemical quality of the products developed, having an obligation to meet the international norms and standards of purity. Concerning the active principals, it undertakes the clarification of the control methods and specifications for the analysis of the raw materials (constituent, reactive, solvents) and of the synthesis intermediates. Its field of activity covers the chemical development and the "process". Concerning the pharmaceutical forms, it takes care of, for the products themselves and their comparators, the pre-formulation research, of the clarification of the methods of control and of specifications of principal activates, of the products of synthesis and of the deterioration of the pharmaceutical forms. 

Also, for the elaboration of the registration files, its field of activity extends to the pre and post EDC research upto phases III. The existing expertise covers the fields of anti-infectious, the bone, endocrinology, the cardiovascular, nervous system and oncology. This expertise uses personnel, infrastructures and high performance materials.

 

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Service of pharmaceutical sciences  

Its role consists of the preparation of formulations for the pre-clinical and clinical development and in the writing of the registration files in respect of GMPs ("good manufacturing practises"). The strong point of this service is to be able to work precociously on the molecules, with a good mastery of the pre-formulation of mixtures. Its competences cover neighbouring fields of application of the service of analysis (polymorphism, size of particles…), the solubilization, and the manufacture of powder in conventional pharmaceutical forms (injectable, freeze-fried, oral form). This service possesses a very effective sterile block.

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Biometry and data processing Dedicated to the conduct, the coordination and the support of projects, this service does the statistical analysis of clinical results and establishes the data bases necessary to the monitoring of the research. It must in addition manage and collaborate with the external organisations (CROs) assigned to certain studies and establish files directly usable for the submission of the products to the registration authorities. Next
Clinical supply. This service prepares and sends the treatments of the clinical studies to the investigators (Aventis products and comparators as well as placebos). There are particular labelling and regulations for each country requiring the presence of at least a pharmacist and a person in charge of the internal quality assurance.
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