Michael Naimark. “Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation.“
Summary: Whether you are a large established pharma/device group, a small biotech company, a startup, or an academic spinoff, getting your medical technology into the clinic will likely require partnering with experienced contract research groups with regulatory experience and the infrastructure to support FDA-targeted projects. In particular, GLP preclinical safety data is frequently the centerpiece of submissions to regulatory agencies.
But how do you evaluate a preclinical CRO to see if they have the capabilities and internal processes in place to ensure your projects run in accordance with best practices and FDA requirements? CBSET’s Director of Business Development, Michael Naimark, presents basic concepts to help investigators better understand how the preclinical CRO operates and what questions and documentation should be part of your evaluation process in the search for a suitable collaborator on your key programs.
More information on this topic is available in related CBSET publications:
Related CBSET brochures:
World Pharma Today: Stem Cell and Regenerative Therapies for Hearing Loss
by Michael Naimark, MS, Director of Business Development at CBSET, Inc. and Marie-Pierre Pasdelou, PharmD, Founder and Chief Development Officer at CILcare
World Pharma Today, Cell-based Therapy and FDA Review: Partnering for Success at Your pre-IND Meeting
by Michael Naimark, MS, Director of Business Development at CBSET, Inc.