Regardless which phase of the product’s lifecycle a company is dealing with – the early clinical stage or even some time after licensing – our collection of publications will demonstrate which challenges a company can be confronted with during the entire process.
Implementing a Pharmaceutical Quality System
Based on our analysis and consultation, a start up sets up new structures and processes allowing them to produce an operate more efficiently along the way to market.
ATMP Regulatory Strategy
We advised the company’s development team in outlining a regulatory strategy that was discussed with the multidisciplinary expert team at the European Medicines Agency (EMA) / Innovative Task Force (ITF).