Universal Regulatory, Inc (URI) provides consulting services in Regulatory Affairs, Regulatory Operations, CMC, Clinical Development and Clinical Operations; combining strong technical expertise in pharmaceutical development with knowledge of global regulatory environments.
We have a successful track record, having worked with ~40 pharmaceutical and biotechnology companies.
URI has established partnerships with consulting firms in EU, Japan, Asia to be able to support client needs for a global development program.
Our service areas include IND, DMF/VMF, CTA, NDA/MAA preparation and review, and life-cycle management, regulatory oversight of global clinical programs, strategic planning, due diligence activities, interactions with health authorities.