CTD / eCTD Dossier Preparation

Excellent preparation of CTD /eCTD Modules is one of the most complicated and challenging aspects of the application process for a healthcare product. Quality Academia has an extensive track record of success in this expertise area.

Our comprehensive method of solutions engage the appropriate experts in the preparation of the applicable CTD/ eCTD modules ensuring the excellent presentation of the technical information to help the regulatory agency in evaluating the submission. 


CTD Format Dossier is very largely used in semi regulated & regulated market like CIS Countries, Middle Eastern Countries, European Union, USA , Australia , Canada, Japan, etc.


-Translation Services

Translation of dossiers, PIL, Packaging, Labeling, Clinical Trial Protocol & Report in more than 50 languages.

-Artwork Preparation

• At Quality Academia we are ready to support you by our qualified and skillfull packaging graphic designers.

• We start to support you from the beginning and help you engage in your package development process. We have a robust artwork management program and can manage your artwork from creation through to post licencing maintenance. 

• Artworks are prepared by our experienced and skillfull designers using most state of the art desktop publishing programs to meet your requirements. 

-Orphan Drug Applications


OUTSOURCE YOUR REGULATORY AFFAIRS


At Quality Academia we do believe that life science organizations reserve a huge amout of their sources such as time, energy and manpower in maintaining the established product portfolio in the market. 

At Quality Academia we do believe that choosing the way of outsourcing your work is efficient, cost effective, competitive approach to focus on and achieve the bigger objectives of your company wherein the potential resources can be efficiently utilized. 

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