Navigate the Future GmbH

𝗝𝗘𝗡𝗟𝗬.𝗔𝗜 is the Agentic AI Assistant for Regulatory Affairs in the Life Sciences.

JENLY.AI is a specialized AI assistant for highly regulated industries such as pharma, medtech, and biotech. We are transforming how regulatory, quality, and compliance teams work. Our Agentic AI Assistant drafts, updates, and manages regulatory and technical documentation—traceably, securely, and at scale. JENLY.AI enables regulatory teams to work more efficiently and productively throughout the product and regulatory lifecycle.

𝗪𝗵𝗮𝘁 𝗼𝘂𝗿 𝗔𝗴𝗲𝗻𝘁𝗶𝗰 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝗱𝗼𝗲𝘀

• Automates complex regulatory workflows: eCTDs and global dossiers; PSURs; clinical evaluation and safety reports; HTA/reimbursement dossiers. Accepts both structured and unstructured inputs (PDFs, Word, Excel, past reports, literature).

• Produces traceable, auditable outputs with sourced statements; it is GDPR-compliant, featuring human-in-the-loop workflows to ensure oversight.

• Built-in domain knowledge: Regulatory, Clinical, Safety, etc., aligned with regulatory requirements.

𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀

Regulatory teams spend 𝘂𝗽 𝘁𝗼 𝟳𝟬% of their time on tedious and mundane tasks such as copy & paste, formatting, cross-referencing, and updating. These tasks slow down approvals, increase costs, and delay patient access. JENLY.AI frees experts from paperwork so they can focus on safety, science, and strategy.

Our vision: To create a world where compliance runs itself—where experts are freed from administrative burdens and regulatory work transforms from a bottleneck into a competitive advantage. But JENLY.AI doesn’t just make your regulatory teams more efficient; we help you accelerate the delivery of life-saving products!