We offer a pharmaceutical development service and are experts in developing injectable sterile drug products in liquid and lyophilized form.

We compile and prepare all the information required for module 3.2.P of the registration dossier (CTD):

  • Development and validation of analytical methods: assay and impurities,
  • stability studies with complete storage service, management of samples, issue of periodic reports, and
  • validation of the manufacturing process.

We manage the transfer of industrial manufacturing; we look for the most appropriate third-party laboratory for you.