Regardless of the document needed for your eCTD dossier content, we would be happy to help.

For Module 1 we create product information and translations thereof, the Risk Management Plan, the Environmental Risk Assessment, and of course the Application Form and other administrative documents.

For Module 2 we support with the writing quality, non-clinical and clinical summaries and overviews. We have a great network of colleagues and partners with the expertise needed for each section.

For Module 3 we write and compile all the chemistry, manufacturing and control (CMC / quality) documents necessary, in collaboration with the drug product manufacturer department or CMO.

For Modules 4 and 5 we collect the applicable study reports and literature references.  

We combine knowledge in writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards. 

When all documents are written and collected for your dossier sequence we also provide eCTD publishing services.