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

Telephone: +46 73 375 9818  |  Email: heather.cook@pharmalogic.se