The name One Realm came from a simple goal: the desire to manage Regulatory Affairs information in one place.

One Regulatory Affairs Lifecycle Management.

Regulatory Affairs professionals spend valuable hours searching through countless resources and aggregating information. Knowing where to find regulations, guidance documents, and other sources of Regulatory Intelligence is one of the most important skills a Regulatory Affairs professional can develop over time.

One Realm aims to provide resources for Regulatory Affairs professionals, consultants and anyone interested in global Regulatory Affairs. Whether you are a veteran or just starting your career in regulatory, One Realm is here to help you keep from being overwhelmed and underinformed.

One Realm's founder is a successful RA professional with two Regulatory Affairs Certifications (US and Devices), a Master's degree in Orthopedic Regulatory and Clinical Affairs, and over 10 years experience in the medical device and in vitro diagnostics industries. Careers spanning US FDA submissions, international registrations, quality audits, continuous improvement, global team management and development allows One Realm's associates to provide the highest level of resources and support to organizations and individuals seeking to simplify a complex regulatory landscape.

The One Realm team has a wide range of medical device and pharmaceutical experience - spanning 25 years of global regulations, international standards and investigations / root cause analysis.

One Realm is a startup out of Southwest Florida. Established in November 2021, services and products offered include:

• Regulatory Affairs Training, Templates, Systems and Intelligence

• Consulting Services (Regulatory Affairs, UDI, CMMC)

• Auditing (Life Sciences, Pharmaceutical and Medical Device)