As of January 1st, 2022
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Preclinical Launched after the development of the prototype, preclinical development includes a series of studies and operations aimed at confirming the product's viability, testing its safety and establishing the scientific bases and regulatory strategy necessary for all applications for clinical trial approval.
Clinical phase 1-2 Phase 1 includes healthy volunteers to assess their tolerance to the treatment. Phase 2 is carried with a limited group of sick patients to assess the treatment's efficacy, the drug's optimal dose and any side effects.
Clinical phase 3 Phase 3 is undertaken with a large number of sick patients to compare the treatment's efficacy to that of a placebo or a standard of care. If successful, this is the final step before the filing for marketing authorization.
NDA Bringing a drug on the market is subject to prior authorization from health authorities such as the FDA (Federal Drug Administration) in the United States and EMA (European Medicines Agency) in Europe. The application for the marketing authorization (NDA) is based on document compiling data from the work carried out during the development of the product.
Market Once all the stages of development and approval have been received by the health authorities, the product is marketed.
In partnership with Teva Pharmaceuticals
In partnership with AIC
Supported by the Bill & Melinda Gates Foundation
Supported by Unitaid
Animal Health product (different clinical development process)
We have designed a structured approach to identify new opportunities and enlarge our portfolio of proprietary and partnered products. This assessment process aims to identify unmet needs in a large panel of indications that could be met with long acting injectable treatments and identify the most compatible APIs with our technology. This preliminary step is essential to significantly increase the likelihood of success for each product entering formulation stage.