Cases |

Success in medicinal product dossier preparation for global markets

When developing a new medicinal product, our client opted for a global approach: they wanted to access all the major markets, and to benefit from synergy, they decided to prepare the CMC documentation for the EU, FDA and Japan authorities simultaneously.

Marketing authorisation granted to the satisfaction of both the authorities and the client

After initially evaluating the scope of the task, our client decided that a CMC consult was required to deliver a suitable CMC regulatory strategy and to reach the goals the company had set. They contacted DRA Consulting, and our experienced CMC experts pinpointed the following action points:

  • writing the Module 3 section for the medicinal substance and medicinal product
  • writing country-specific sections for major global markets
  • evaluating the dossier by a senior expert to meet the authorities’ requirements
  • offering strategic consultation during the writing process
  • following the given timeline for the submission

Solutions Offered by DRA

  • Three experts were appointed to the project team. Two of them wrote Module 3 sections and the senior expert evaluated the dossier. In addition, project manager followed the project and prepared reports for the client.

Benefits Delivered

  • The dossier of high quality was ready for all targeted markets as planned.
  • DRA experts offered additional recourses flexibly along with the development process. 
  • The dossier was finalized in time for submission.
  • The marketing authorization process was very smooth, and the CMC section passed the authority assessment without any major questions in all global markets.

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