Services
Strategic Solution for Your Drug Development Journey
In nonclinical development, every piece of information is connected.
We provide a dense, resilient strategy to prevent gaps and ensure success.
Nonclinical Development Strategy
-
Customized strategy development considering modality, indication, and target product profile (TPP).
-
Gap analysis for IND submission readiness.
-
End-to-end project management (Master schedule & CRO management including communication)
Study Design & Oversight
-
Detailed study protocol development (Dose, endpoints, sampling time points and more)
-
Raw data review, result interpretation, and troubleshooting.
-
Review of draft reports and suggestions of revisions.
Specialized CRO Connection & CRO Oversight
-
Selection of validated testing facilities and tailored to specific study needs.
-
Comparative quotation analysis and contract management
-
Quality review, timeline monitoring and project management
IND Documentation
-
Review draft regulatory documentation
-
Development of Investigator's Brochure (IB)
-
Writing Common Technical Documents (CTD): Module 2.4, Module 2.6 and Module 4.
Every Step of Our Work
Tech Valuation &Licensing Support
-
Valuation of nonclinical and early-clinical stage pipelines.
-
Scientific due diligence based nonclinical data
-
Support for technology transfer and valuation
