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: firstname.lastname@example.org