Review and/or Preparation of key submission documentation

All communications with regulatory agencies are formal and need to be aligned with the strategic plans.

The messaging should be consistent within, and across, documents, and the importance of having a “red thread” throughout the submissions, and indeed, throughout the development of the product cannot be underestimated.

  • Orphan drug designation submissions
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigational New Drug (IND) submission

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