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Regulatory Technology Intelligence Program

The Regulatory Technology Intelligence Program is intended to help partnering companies maintain an in-depth understanding of current regulatory guidance on technology and clinical information management. This facilitates making timely strategic and tactical direction decisions without maintaining a full time employed expert.

In today’s fast-paced information technology world, the regulatory authorities issue opinions, direction and guidance in an accelerated manner. This impacts both short-term and long-term corporate decisions on delivering regulatory compliant systems, processes and information to their clients and the regulatory agencies. The recent decision of the FDA to rescind some components of 21 CFR Part 11, along with the re-examination of the entire guidance position on technology and electronic records leave corporations with unanswered questions as to the direction the agency will move on these critical areas.

LookLeft partners, that have extensive technological and regulatory expertise, provide the integration of regulatory intelligence with deep, comprehensive, technology direction. LookLeft partners deliver focused, comprehensive analysis and direction to organizations needing executive level evaluation of the emerging trends and guidance in the evolving world of clinical information analysis and management.

 

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