Regulatory Affairs

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

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