European Manufacturing & Logistics Scale-Up

Client is on fast track to receive CE Mark approval and launch product commercially in Europe within six months. To meet expected demand the company must rapidly transition from low-volume, in-house manufacturing to high-volume, proven contract manufacturers. In addition, the client requires substantial changes to product packaging and labeling. EU logistical support must also be established.

ACTIONS

Led weekly internal project team meetings
Evaluated and signed agreement with EU logistical distribution partner
Identified and conducted due diligence on five Irish contract manufacturers
Negotiated and signed three year supply agreement with Irish contract manufacturer
Evaluated and selected EU sterilization house
Incorporated redesigned packaging and labeling
Identified and recruited EU Operations Manager
Secured sterilization and validation expert (part of MedCelerate partner network)

RESULTS

First commercial product shipped by new logistical distribution partner within 90 days of project start
Initial finished goods inventory with new packaging configuration available six months after project start
Capable and robust supply chain established to meet future commercial launch requirements
Established internal EU operational capabilities

VALUE

Ability to generate significant international revenue; reducing future funding needs
Elimination of key risk factor for acquisition by strategic player
Positions client for future FDA pivotal trial requirements