Generative AI for
Life Sciences
Life sciences AI connected to all your data. Find, create, and automate anything.
Trusted by leading life science organizations
Empower teams with a secure, enterprise-ready platform
Regulatory
Accelerate approval processes with AI.
Quality
Automate audit trails and ensure GxP compliance.
Sales
AI-powered sales intelligence and pipeline management.
A new platform
for life sciences
510(k) Submission Requirements
Internal SOP-REG-001
Company procedures for preparing and submitting 510(k) applications. Includes templates, checklists, and guidance for substantial equivalence determination. References FDA guidance documents and submission requirements...
EU MDR Technical Documentation
MEDDEV 2.7/1 rev.4
Ask anything across your enterprise and industry data
Access all your internal data and our library of industry data to get instant guidance on FDA, EU MDR, and international regulatory pathways while maintaining alignment with company procedures.
[ Quality Management System Updates ]
Document Control Update
Quality Manual Section 4.2.3 updated to align with ISO 13485:2016 requirements.
Just now - 08:02am
Automate entire workflows
Automatically track and update quality system documentation to ensure compliance with ISO 13485 and FDA 21 CFR Part 820. Streamline document control, change management, and quality system procedures.
Key discussion points captured and analyzed by AI, providing actionable insights for your team.
Accelerate your teams
Streamline your workflow with automated notetaking, CRM updates, and insights. Automate the busywork so you can get back to what matters, building relationships and bringing life changing products to patients.
Enterprise Security
Built by security experts with over a decade of experience in developing systems that meet the most stringent security standards
- Client questions & data are never used for training
- Isolated data storage
- Regularly audited & tested by third-party security specialists
Tailored solutions for you
We collaborate with your team to build custom software that solves your specific problems.
Valkai offers a suite of modular, customizable tools that seamlessly integrate into your company's unique workflows.
Your trusted partner
“Valkai has been exceptional at explaining what they can bring in and finding data sources I didn't even know existed.”
“Every time we bring up another data source, they find a way to integrate it into what we're trying to do.”
“They've allowed us to pull all our core data into one system. The difference that makes in our daily work is remarkable.”
“What Valkai delivers is on another level, because it's pulling from our own validated sources.”
“The first time someone got an accurate, cited answer in seconds, they were sold.”
“Valkai has been exceptional at explaining what they can bring in and finding data sources I didn't even know existed.”
“Every time we bring up another data source, they find a way to integrate it into what we're trying to do.”
“They've allowed us to pull all our core data into one system. The difference that makes in our daily work is remarkable.”
“What Valkai delivers is on another level, because it's pulling from our own validated sources.”
“The first time someone got an accurate, cited answer in seconds, they were sold.”
“Valkai has been exceptional at explaining what they can bring in and finding data sources I didn't even know existed.”
“Every time we bring up another data source, they find a way to integrate it into what we're trying to do.”
“They've allowed us to pull all our core data into one system. The difference that makes in our daily work is remarkable.”
“What Valkai delivers is on another level, because it's pulling from our own validated sources.”
“The first time someone got an accurate, cited answer in seconds, they were sold.”
