• Characterization of original product and active substance
  • Compatibility studies of the active substance with excipients
  • Risk assessment

Laboratory Scale Studies

  • Process selection.
  • Development of the laboratory scale production process
  • Final formula approval
  • Stability

Pilot Scale Studies

  • Scale-up production.
  • Development of the pilot scale production process
  • Pilot batch production
  • Pilot batch stability studies


  • Risk assessment
  • Pilot bioequivalence study
  • Pivotal bioequivalence study


  • Registration file compilation for submission to the Health authorities
  • Follow-up the submitted files during regulatory process

Supply Chain

  • Determination of the appropriate suppliers
  • Selection of the most efficient and economical means of transportation
  • Management of the import process
  • Management of the customs process
  • On time delivery