Dossier

Extract data to a balanced level of details

Efficient preparation of the marketing authorization dossier (Modules 1-5)

  • Module 1: Preparation of the regional information
  • Module 3, 2.3: Technical writing Quality, also ASMF & CEP
  • Module 4, 2.4, 2.6: Medical writing Nonclinical
  • Module 5, 2.5, 2.7: Medical writing Clinical

Our specific expertise revolves around the entire marketing authorization dossier. We create and update the legally required information for modules 1-5 and implement the necessary data for the Quality (CMC), Nonclinical and Clinical modules.

Effective dossier preparation

We efficiently carry out the complex review and adaptation of foreign dossiers for submission in Switzerland. We carry out extensive literature searches and evaluate them for use in the authorization dossier (bibliographic submission). Our activities also include the preparation of the entire electronic dossier (eCTD, eDOK) and the reformatting of existing dossiers. We efficiently convert an existing CTD authorization into the eCTD format.