Dossier Creation

Dossier Creation

Competent solutions for complex problems.

A various number of documents need to be compiled and submitted for the application and maintenance of marketing authorisations of healthcare products - which vary depending on the product category.

PRSG supports in the evaluation and preparation of the documentation that has to comply with highest quality standards all over the world. The documents are always prepared  in cooperation with our clients and according to the companies' internal guidelines.

We can compile a complete dossier (module 1-5) or support in compiling individual modules. We revise, evaluate and maintain all sort of dossier related documents. The dossiers comply with the high quality standards and requirements of the European authorities and the international standards of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

eCTD, NeeS or vNeeS - we can provide you with any electronic submission format!

  

 

Our services include:

Evaluation of new or existing regulatory documents

Preparation of the quality dossier  
- planning
- compiling
- updating
- reformatting

Preparation of expert statements, overviews

eSubmissions