Drug Developement Plan Design

Work-Packages, budget and financing plan estimation, management of CRO/CDMO externalized tasks performed in CRO or CDMO

The full listing of experimental non-clinical studies is suggested to partners. Key-points are animal species choice and doses selection in toxicology, pharmacology and DMPK studies. BIOPHACT® provides recommendations and rationales for studies design, and justify the relevance of non-clinical studies. Regarding chemical control and manufacturing, BIOPHACT® plans drug supplies for each step of the project, in accordance with the intended route of administration that meets all trial needs in compliance with the current regulation rules.

We are fully integrated to CRO/CDMO ecosystem and belong to an efficient network of services providers worldwide.
We can manage studies for partners and carefully evaluate the cost of each task and challenge the CRO/CDMO.

A such benchmark gives a clear view of the overall cost of the program.

Listing of experiment needed to show a differentiation vs competitor in safety, efficacy, treatment compliance, administration route, companion diagnostic, support the clinical pathway of the drug development.

BIOPHACT® optimize the R&D development plans, keeping in mind:
Thorough evaluation of costs and timelines increase the credibility of the Project for VCs, investors, Experts and Competent Authorities.

Drug Development Strategy

Costs and timelines