Dossier Maintenance

Dossier Maintenance

Planning - Reorganizing - Supporting

The area of Regulatory Affairs changes continuously, since formats have to be modified and adapted according to current knowledge and updated legal requirements.

We take on the maintenance of marketing authorisation dossiers combining efficiency and high quality work. Our team supports you across a product's complete life cycle, either for partial projects or in leading function for a complete marketing authorisation project - depending on the support you require.
 

 

Our services include:

(Electronic) submission formats:
  - eCTD - electronic Common Technical Document
  - NeeS - Non electronic eCTD Submission
  - vNeeS - veterinary NeeS
Dossier management and -revisions
Dossier reformatting: NTA ? CTD ? eCTD
Product Information Update (SmPC, PIL,
     labeling)
Preparation of Periodic Safety Update
     Reports (PSUR)

   

Marketing Authorisation Dossier

The dossier-format "Notice to Applicants" (NTA) has been replaced by the "Common Technical Document" (CTD) in 2003. Its electronic version (eCTD) is the nationally and internationally recommended format for the submission of marketing authorisation dossiers.

PRSG compiles all types of dossiers (CTD/NTA) for human and veterinary medicinal products or medical devices class 1, nutritional and dietary supplements, cosmetics and wellness products.

Upon request we revise or maintain all documents and adapt them to the distinct (national) requirements including the compilation of Module 1 according to regional demands.

 

Product Information

In addition, the product information of a medicinal product undergoes a very active life cycle, since readability tests as well as new scientific evidence on efficacy and safety directly influence the summary of product characteristics and package leaflet of a medicinal product.

For the purpose of a European harmonization the "Quality Review of Documents" - Templates (QRD) are published and updated continuously. Already existing texts as well as texts that are part of an on-going marketing authorisation procedure have to be adapted to these templates steadily.