Elly can act as your Personal Regulatory Affairs Assistant. Designed for Regulatory Professionals, the Assistant simplifies the complex landscape of global regulations and eliminates language boundaries at your fingertips.
Elly is a medical device and In-vitro diagnostic trained Regulatory Affairs Assistant who can provide insights and clarity on laws, regulations and guidances globally. Built on advanced AI technology, Elly offers an interactive interface for Regulatory Affairs Professionals to navigate and understand complex regulatory documentation.
Elly provides with the news feed an actual overview of new or updated regulations and guidelines in the following countries: USA, Europe (all members), Canada, Brazil, India, Australia, Japan, UK, China, Saudi Arabia, Switzerland, and Singapore. And thanks to Artificial Intelligence users can directly interact with specific documents.
Reading, understanding, and writing are three main activities during a regulatory assessment and are often very time-consuming. With Elly, you can speed up this process dramatically.
The assessment is structured as follows:
By clicking on the “Intended Purpose Creator” Button Elly will start asking you questions about the product. After all questions are answered, Elly will create a suitable intended purpose based on the information the user has provided.
Making the right classification based on the Intended Use is another very important step. Elly can based on the intended purpose and additional required information help to identify the right classification.