As of 1st June 2016, all EU marketing authorisation applications for new pharmaceutical products or new products containing an established active substance must now comply with the requirements of ICH Q3D. This includes completing and documenting a risk assessment and having this available for inspection.

At Butterworth, we have been supporting customers in the lead up to these changes providing analysis by ICP, where required, to assist the completion of risk assessments and determine the requirements for ongoing testing. We have also validated excipient, API or product specific methods where elements of concern require routine monitoring.

Download our recent whitepaper to find out more about the key time-frames for implementation in the EU and US and considerations for ensuring compliance.

If you would like to speak to us in more detail about the analytical approaches then please do not hesitate to contact us.