Drafting of dossiers

Drafting of dossiers:

The laboratory AR2i offers its expertise in drafting the pharmaceutical part (module 3) of Market Authorisation (MA) registration dossiers for new applications, variations or renewals. We can also offer you assistance with the administrative part of the dossier (module 1).

We can:

  • Evaluate your current dossier
  • Guarantee the coordination and follow-up of your project
  • Prepare module 1
  • Draft module 3 in CTD or eCTD format
  • Prepare an ASMF (EDMF)
  • Draft a QOS (Quality Overall Summary)
  • Compile and publish an eCTD dossier and manage its life-cycle

Complete technical development of a drug can be provided for via collaboration with one or several partners (third party manufacturer, subcontractor, etc.).

The AR2i laboratory also works in conjunction with renowned pharmaceutical experts and consultants specialised in international registration.

dossier-s

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