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Dossier Creation

  • Evaluation of new or existing regulatory documents

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

  • Preparation of expert statements, overviews

  • eSubmission


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 and 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).

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