University of Calgary - Advanced Contract Award Notice / Notice of Proposed Procurement - Specialized Regulatory Consulting and QMS Development Services

The University of Calgary (UCalgary) intends to award a master service agreement to Aetherium Regulatory Consulting LLC (ARC) for specialized regulatory consulting and Quality Management System (QMS) development services. These services will support the design, development, regulatory strategy, and eventual regulatory submission of a novel wearable medical device being developed under Clinical Neurosciences research program. ARC supports medical device manufacturers with their regulatory needs. With over 10 years of biotech and regulatory experience, ARC has successfully supported a diverse range of medical devices from inception all the way to commercialization. They offer a wide range of services including regulatory consulting, clinical trial review, and post-market support. ARC’s proposal has been determined to be technically suitable and financially feasible for the full scope of required services. It is the project team’s understanding that Aetherium Regulatory Consulting is the only supplier able to meet the full set of technical, regulatory, and operational requirements for this project in an integrated delivery model.