Services

Pre-Clinical Safety Inc. increases the productivity of the Pharmaceutical business through the use of integrated biology systems for early, and accurate, decision-making. We provide:

• Expert advice on drug discovery and development for decision making on compound selection, development and early elimination for the right reasons
• Resolution of pre-clinical safety issues to enable the development of products through remediation strategies for late developing safety risks
• Advice on strategies for comprehensive pre-clinical and clinical development of products adapted to the therapeutic indication and to the evolving regulatory environment in the USA and globally
• Advice on the organization of scientific teams for better productivity and talent retention and development
• Assistance in preparation of documents for submission to regulatory agencies globally, and in the preparation of scientific position papers to address specific pre-clinical safety issues
• Participation in pre-clinical CRO selection, qualification and ensure the quality of the conclusions (including histopathological conclusions) from pre-clinical studies to separate inaccurate attributions from relevant ones
• Design and oversee the conduction of pre-clinical safety studies in CRO’s on behalf of the sponsor for better coordination of multiple CRO’s
• Assistance for non-USA based pharmaceutical and biotechnology companies to access and comply with the regulatory environment in the USA
• Participation in Due Diligence teams for Venture Capital investments or in-licensing of products.