BrightInsight-built companion app receives CE mark

Ce logo

We are pleased to announce that a BrightInsight customer, a leading global biopharma company, has received CE mark approval for its patient companion app built on the BrightInsightTM Platform, the leading global cloud platform for biopharma and medtech regulated digital health solutions. The patient companion app was reviewed by a Notified Body and the approval was received within four months of submission. This approval affirms that the product meets all relevant EU regulations.

We work with many of the world’s largest biopharma companies. We have been partnering to develop and launch regulated companion apps for both established and newly-approved drugs, as well as combination products. Many of our projects support complex administrations for patients across a range of disease states including diabetes, respiratory, oncology, rare disease, ophthalmology, immunology among others. In each case, our team works with our customers’ internal digital, R&D, commercial and brand teams, to build apps that support the patient journey at every step. Our team participates in audits and reviews with the Notified Body as part of the approval process.

By building the app on BrightInsight Platform, which was developed using our ISO 13485-certified Quality Management System, our customers can feel confident that compliance to all EU regulatory, security and privacy requirements are met, and that all necessary documentation is available to support regulatory submissions. BrightInsight also supports our customers throughout the submission review process and any subsequent audits to ensure our customers’ products are approved and launched successfully. The app supports patients with a specific chronic condition that requires an injectable medication by enabling them to track and manage their disease status.

The CE marked app includes the following capabilities:

This latest companion app, and all digital solutions we build on the BrightInsight Platform are developed with scale in mind. With our pre-built modules and global compliance, our biopharma clients can easily and quickly scale across geographies and disease states.

We’re excited to announce this exciting achievement, and look forward to sharing more about this project when it is made public.

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