Add your company and products once. Elly then tracks every relevant regulation, standard, and change for you — and turns each update into a ready-to-use impact assessment. Use it as a SaaS today — or as the operations layer built into your existing systems.
Elly is a complete SaaS you can start with today. It is also a regulatory operations layer: the layer above your eQMS, RIMS and document systems that runs the regulatory change process — and, after your approval, delivers the result where your team already works.
Today Elly keeps you automatically up to date. Next, every relevant change arrives as a prepared action — ready for your approval.
Regulatory Globe GmbH is a Swiss company specializing in regulatory intelligence for the medical device and IVD industry. We understand the daily challenges of RA professionals because we come from the same background.
Our platform Elly was born from a simple insight: regulatory professionals spend up to 80% of their time searching, reading, and compiling information — instead of applying the expertise they were trained for. We built Elly to change that — and to run the regulatory change process as a layer above the systems companies already use, not as yet another system of record.
Every alert and assessment Elly delivers is traceable to its source — specific articles, clauses, and guidance documents. No speculation, no generic summaries. Swiss precision in regulatory operations.
Regulatory work means handling sensitive product files, IFUs, and internal assessments. With Elly, that data is processed exclusively by AI hosted in Switzerland — it never leaves Swiss jurisdiction, it is never sent to US cloud providers, and it is never used to train AI models.
Without a structured operations layer, AI stays an experiment. With Elly, it runs your regulatory process — every change assessed, every action prepared, you sign off.