While the focus of our Services is on Quality, i.e. the Technical Development of your New Chemical Entity, Biologics or Life-Cycle Drug, an in-depth understanding of Regulatory / Authority requirements is essential.
In co-operation with your Regulatory Affairs Department or senior consultants from our global network we
– develop / support Regulatory Strategy for EU, US, Japan, Asia Pacific and LATAM submissions
– review/ write IMPDs &INDs
– support/ manage Scientific Meetings with Authorities
– review/ write technical summaries, expert reports and quality related documents
– respond to objections from Competent Authorities during CTAs/INDs or MAAs/NDAs
– support regulatory procedures for EU MAA – Centralized, Decentralized, Mutual Recognition – and US NDAs