Assistance with regulatory procedures

Are you wondering what ICH, IB, IND, IMPD, IRB or IQ/OQ/PQ mean?

Would you like to understand the differences between the centralised, the decentralised, the mutual recognition and the national application procedures?

Are you trying to find out what the requirements are for your drug for the first-in-man study in the various European countries, the US, Switzerland, Canada, Australia, Japan, South Africa, the Middle East, South or Central America?

Or are you looking for support handling a focused and structured compilation of your eCTD which complies with the ICH guidelines and the regional specifications?