Other Services

As consultant and an advisor :

  • We can provide assistance with contacts with Health Authorities worldwide,
  • Develop regulatory strategy on drug development plans,
  • Prepare your regulatory dossiers,
  • Clinical trials, New applications, Line extension, Variations, Renewals, IVD’s, Cosmetics Regulation.

 

As temporary staff :

  • We can provide temporary help on-site or off-site during peaks in
    workload or to cover for any absences.

 

As an agent :

  • Based in Switzerland, and having a branch in France, we can represent
    your Company in Switzerland and Europe.

 

As a trainor :

  • Regulatory training and education on any specific European regulations
    or more general topics.

 

eCTD

The eCTD is the electronic version of the Common Technical Document.

Since January 1st, 2010, the EMEA will mandate the use of the eCTD format for all electronic only submissions for all applications (new and existing) and all submission types under the Centralised Procedure.

  • Compilation and publishing of the eCTD.
  • These eCTDs will include hyperlinks and bookmarks.
  • DVD duplication.