Bespoke regulatory services for a smooth submission validation

Orphix regulatory consultants advise and assist clients with a complete electronic Common Technical Dossier (eCTD) service for new drug applications and life cycle management. 

Our team of qualified publishing and submissions experts has comprehensive knowledge of global regulatory publishing trends and submission formats. We support clients by using a robust publishing and submission software, which guarantees error-free submissions, a transparent process and a quick turn-around time. Outsourcing e-submission projects to Orphix enables the client organisation to focus on core business functions and reduce additional overhead costs. 

Our comprehensive eCTD services include:

  • Project management of all regulatory submissions
  • Formatting and editing of regulatory documentation and references for submission
  • Verification and insertion of appropriate document hyperlinks
  • Country-specific composition, publishing, and validation for submissions in the US, EU, and worldwide
  • Secure transfer of submission through our company FDA/EMA gateway
  • Document authoring and medical writing services
  • Storage and archive of the eCTD dossier