Insuvia provides a one-stop solution to pharmaceutical companies looking to build up a regulatory dossier from scratch. That is why we assure you – we carry out our work in a timely and high-quality manner with the help of our highly qualified field experts.

Our medical writing and regulatory affairs teams prepare documents required to support the applications at all stages of product lifecycle in compliance with applicable regulations and standards, ensuring that the efficacy, safety and quality of your medicinal product is demonstrated properly.

We can help with full development and formatting of your regulatory dossier to be submission ready:

  • Development of Non-clinical Overview/Summary (Modules 2.4/2.6) 

  • Development of Clinical Overview/Summary (Modules 2.5/2.7) 

  • Development of Quality Overall Summaries (Module 2.3) 

  • Preparation of Addendums to Clinical Overview 

  • Development of Summaries of product characteristics (SPCs) and Package Leaflets (PL) 

  • Package Leaflet Readability User Testing (RUT) or Bridging Reports (Module 1.3.4) 

  • eCTD publishing activities using a fully validated system 

  • Risk Management Plans (1.8.2) 

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