BaselBio1 Gmbh is a consultancy that supports small biotech companies and academic research groups in drug development. Services include designing development strategies and plans (CMC, nonclinical and clinical programs, timelines and budgets), selecting CMOs and CROs, regulatory strategy and health‑authority meeting preparation, NDA/MAA filing support, and due diligence on in‑licensing candidates.
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Industry:Management Consulting
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Advisory for pharmaceutical development strategies
Design of pharmaceutical development strategies and plans, including realistic budgets and timelines, CMC, preclinical and clinical planning, and support for regulatory strategies.
Support in selecting CMOs and CROs
Identification of suitable CMOs and CROs for API and drug development, preclinical studies, clinical programs and Phase 3 execution.
Due diligence for in-licensing candidates
In-depth analysis of available data on potential in-licensing compounds, including a risk-benefit assessment and projection of remaining development costs and time to market.
Support for clinical development and study planning
Design of Phase 1 programs, assembly of clinical advisory boards, drafting of Phase 2 and Phase 3 protocols, and support for Phase 3 execution.
Advisory on NDA/MAA submission strategy
Development of the NDA/MAA filing strategy and guidance through to the successful completion of the regulatory submission.
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