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

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 evaluation of integrity parameters

Material selection

Compatibility issues

Selection of appropriate closure, gasket and container

Stereolithographic prototypes

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

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

Generation of Drug Master Files

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

Device documentation for submission

Evaluation of appropriate contract fillers

• liquid

• powder

• aseptic filling

Providing contract design and manufacturing service

Support in the realization of device IP’s