Development of the marketing authorisation files


With a portfolio of more than 40 projects, we assist our customers in all steps, including: :


  • The study of feasibility
  • Evaluation of intellectual property and tracking technology watch
  • Selection of active substances and functional excipients
  • Pre-formulation / formulation / process validation
  • Validation and transfer of analytical methods
  • Stability studies according to ICH guidelines
  • Drafting of the marketing authorisation files in CTD Module 3 according to international standards ICH
  • The industrialization of products and their possible transfer
  • Preparation of files of food supplements,biocides, medical devices, etc …


Generika develops drugs in the following forms:


  • Pasty: cream, ointment, gel, and emulgel
  • Semi-pasty: suppository and pessaries
  • Liquid: solution and nasal suspension, syrup, solution, oral suspension, eye solution, lotion.
  • Dry and injectable: ongoing.