As the project advances towards first-in-human (FIH) clinical development, Delbios is preparing the key regulatory and clinical documentation required for a future Clinical Trial Application (CTA) submission.
To support this process, Delbios intends to subcontract specialized regulatory and scientific consulting services for the preparation and/or review and optimization of:
- Investigator Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
- Phase I Clinical Study Synopsis
The objective is to ensure that these documents are scientifically robust, internally consistent and aligned with current EMA, ICH and EU Clinical Trial Regulation requirements prior to CTA preparation.
All quotations must be submitted by 29/06/2026 to: info@delbios.com
Subject: SRD12-RFQ-TOX-010-2026
