LEA, Non-Clinical Safety Consultancy
Pharmaceuticals - , Center District, Israel
LEA, Non-Clinical Safety Consultancy Employees
LEA, Non-Clinical Safety Consultancy Details
A European registered toxicologist (ERT) with over 18 years of experience in the Pharma industry, mainly with preclinical development of innovative drugs, Re-positioning (new therapeutic entities) drugs and generics.Providing customers with the following services:* Establishing the needed NCS package of different molecules (small and biological) in relation to the drug mode of action, clinical stage to be supported and the regulatory requirements. Different preclinical package is established for innovative drugs (small or biologic) vs. repositioning or generic drugs.* Selecting the appropriate laboratory (CRO) for a given drug/device.* Contracting, supervising and monitoring preclinical studies at CROs.* Producing high level NCS protocols and reports according to either non-GLP or GLP requirements.* Communicating and consulting with key opinion leaders in order to promote the project.* Writing the NCS texts for regulatory submissions (IB, IND, SA).
