We not only have the know-how regarding manufacture and quality systems. As your One-Stop-Shop, we have qualified and experienced experts to assist you at any stage of the application process.
On request, we will assess your existing documents or we will compile the required registration documents – based on your or your partner‘s raw data – complete CTDs or individual documents as required. If you don’t have the suitable resources available we can monitor the follow-up as well. Our main focus lies on the EU markets.