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Case Studies

End-to-End 505(b)(2) Submission Support

Background & Problem

The client needed guidance on their program from start to finish, and there were complications obtaining the reference listed drug (RLD). We engaged the client prior to the IND-enabling program by conducting a gap analysis (US IND and EU IMPD submissions) and developed a comprehensive nonclinical development plan. Nuventra managed the pre-IND meeting that included a face-to face interaction with the FDA and acted as their regulatory affairs point of contact. We also prepared the full briefing packet for the meeting and managed the meeting follow-up.

Our Solution

To address the RLD availability issue, Nuventra devised alternative strategies that were approved by the agency during the pre-IND meeting.

To support the overall program, Nuventra authored the full IND submission in eCTD format that included publishing, compilation, and submission through the FDA’s electronic submission portal. Nuventra then designed and managed two Phase 1 clinical studies, including end-to-end support with protocol authoring, monitoring, site management, data management, biostatistics, PK analysis, and clinical study report authoring.

Outcome

Nuventra was integral in preparing and submitting the client’s 505(b)(2) NDA submission, including scientific input, authoring, and publishing. The client is expecting NDA approval in 2020.