Services for Pharma and Life-Science

 

 

Regulatory Affairs

 

We provide consultancy to all national and international regulatory issues that are within the scope of drug development (Drug Substance, Drug Product) is important. We do not just talk about it, but we write and understand what we write because we are scientifically trained "Technical Writer". We represent here our company name "Chemistry - Manufacturing and Controls, CMC" and create all necessary documents required for modules 2.3 and 3 according to regional and international registration in eCTD format "electronic Common Technical Document".

 

Regulatory

Structure of the electronic Common Technical Document (eCTD) according to >> ICH M4.
CMC Pharma GmbH creates and reviewes all the documents necessary for modules Modules 2.3 and 3.