For too long, our best minds have been buried in paperwork. We say: No more! This is our stand against the burden of regulatory compliance.
JENLY.AI eliminates the manual effort in regulatory, quality, and compliance documentation in highly regulated industries like Pharma, MedTech, and Biotech
Today, regulatory teams spend up to 70% of their time on low-value tasks – cutting, pasting, cross-referencing – under rising workload and compliance pressure. JENLY.AI automates these workflows using AI, so experts can focus on strategic decisions, not formatting PDFs.
Introducing Jenly.ai

What if compliance documentation could write itself?

JENLY.AI is your domain-specialized AI assistant that drafts, updates, and explains regulatory documents – traceably, securely, and at scale, including tasks to be done that lead to those documents. JENLY.AI can take over tasks, educate people and answer questions about the product & regulatory space.

Unlike general AI tools, JENLY.AI is purpose-built for regulated environments

Built-in knowledge of CTD, HTA, PV, and QA documentation standards

Traceable outputs and audit trails for compliance

GDPR privacy and security by design for EU standards

GDPR privacy and security by design for EU standards

Think of JENLY.AI as your digital regulatory specialist. The frontline operator. Not merely suggesting, but acting, delivering, and ensuring that compliance is completed with precision and assurance.

Our Vision

The future of regulated work isn't about copilots. It is where autonomy meets purpose.

For decades, the most brilliant minds in Pharma and MedTech have been trapped by administrative work. We are ending that era. 
Our vision is a world where compliance runs itself. Where experts are liberated from the relentless burden of documentation to focus on the science that changes lives. 
Our AI-driven operators do more than save time; they accelerate the delivery of life-saving therapies, ensure higher standards of quality, and empower companies to lead in their fields, not just comply with them.
Product Status

Our MVP is live and piloted successfully in regulatory and clinical use cases with early customers.

We’re now scaling product capabilities and extending integration into IT ecosystems (e.g. DMS, QMS, LIMS).
Drafts sections of eCTD, PSUR, and other reports
Ingests diverse sources: PDFs, Word, Excel, legacy reports, CSV, etc.
Provides explainable, fully sourced output
Delivers a secure, GDPR-compliant SaaS experience
The team

Reimagine Regulatory - Together

Behind JENLY.AI stands a group of builders and visionaries, each with deep roots in the worlds of regulation and technology. Our team’s 100+ years of experience across MedTech, Pharma, AI, and SaaS is more than a number, it’s a testament to our shared mission: to liberate experts from administrative burden and set a new standard for compliance.
Dr. Daniel Kapfer
CEO / Co-founder
Founder and leader in Pharma, MedTech, and Academia with over 15 years’ experience automating processes. Expert in AI-driven regulatory innovation. Background in Physics and Medicine, combining scientific depth with entrepreneurial impact across life sciences.
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Rusty Miller
CTO / Co-founder
Experienced software leader with 20+ years building high-performing teams at Microsoft (Visual Studio, Dynamics, Skype/Teams) and leading AI startups (AID, e-bot7). Expertise in B2B SaaS, enterprise software, developer tools, and AI. Background in Mathematics.
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Join us in building the future of regulatory compliance.
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