service

device strategy

  • Assessment and definition of the requirements of delivery systems

  • Market research and analysis of the existing market

  • Standard delivery device vs. customized delivery device

  • Generation of intellectual property rights

device technology

  • Evaluation of the appropriate dispensing technology

  • Evaluation of secondary add-on features

  • Investigation and implementation of existing technologies

  • Assessment of the feasibility

  • Technology transfer into a mass product

technical service

  • Technical evaluation of integrity parameters

  • Material selection

  • Compatibility issues

  • Selection of appropriate closure, gasket and container

  • Stereolithographic prototypes

analytical service

  • In-vitro performance characterization of the dispensing system

  • Microbiological evaluation of preservative free systems

  • Generation of test protocols

  • Development of test methods

  • Harmonization and validation of test methods and equipment

regulatory support

  • Support in regulatory device issues in accordance with the current regulatory guidances of the FDA and EMEA

  • Generation of Drug Master Files

documentation dossiers

  • Generation of dossiers for CE-marked "ready-to-market" products

  • Device documentation for submission

contract filling

  • Evaluation of appropriate contract fillers

    • liquid

    • powder

    • aseptic filling

contract manufacturing

  • Providing contract design and manufacturing service

  • Support in the realization of device IPís

contract manufactoring contract filling dossiers support_regulatory analytical service technical service device_technology deice strategy