Case study

A European biotech company

Reconstitution and injection system for a leading biotech

PA worked with a leading European biotech company to manage the development of a reconstitution and injection system. PA undertook an extensive US and European Usability Study and managed a detailed test programme, refining the design of the device and providing the technical documentation for a regulatory approval submission. PA also coordinated a team of 9 vendors to provide verification and trial batches of product, together with the necessary manufacturing records.