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Pharmaceutical project management
Project management for new therapeutic agents for immune-inflammatory diseases, from target validation through Phase II Proof of Concept clinical trials.
Strategic planning CMC, nonclinical, regulatory and clinical
Strategic planning and management of CMC, nonclinical, regulatory and clinical activities, with coordination of the development process up to the clinical phases.
Interaction with competent authorities
Direct interaction with FDA, EMA and competent local authorities for R&D plans and related activities in pharmaceutical development.
Outsourcing of R&D, manufacturing and distribution
Management of outsourcing in research and development, manufacturing and distribution, while maintaining strategic coordination of development activities.
Coordination of scientific partners and CROs/CMOs
Creation of ad hoc teams with universities, research institutes, specialist consultants, nonclinical CROs, manufacturing CMOs, and global and local clinical CROs.
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