Empower Your
Regulatory Affairs
Team with AI
Automate document assembly, ensure compliance, and accelerate approvals.
Improve collaboration, reduce errors, and ensure consistent responses to health authorities.
How A79 helps
A79 empowers Regulatory Affairs teams to automate manual tasks, improve document quality, and ensure compliance with ever-evolving regulations, leading to faster submissions and approvals.
Filing Assistant
Automated document assembly
Error and inconsistency detection
Document compliance review and approval routing
Real-time collaboration with built-in version control
2 new Adverse events found :
3 HCPs reported Gastrointestinal issues due to GLPs. View raw data
Ocular Toxicities: 2 Dry Eye syndrome were found. View raw data
What are the results if CancerX drug is combined with radiation therapy.
There is no conclusive studies which combine results of radiation therapy with CancerX. However there are a few the ongoing studies (Link 1, Link 2), which show proof of concept for patients with liver metastases.
Health Authority Response
Create draft responses with references to supporting documentation
Ensure consistent response to similar questions from myriad health authorities
Check for incomplete responses or extraneous material
Understand the scope and intent of regulatory inquiry
The features
Regulatory Affairs
teams love
Export to Documents
Seamlessly integrate with your existing pharma systems and data sources for a unified and comprehensive view.
Automatic Citations
Generate accurate citations for all your data sources automatically, ensuring transparency and compliance.
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AI-Powered Worksheets
Easily extract structured attributes out of unstructured data. Collaborate with AI-powered worksheets that streamline analysis and accelerate decision-making.
Dashboards with re-usable insights
Create interactive dashboards with customizable widgets to monitor key metrics and share insights across your organization.
Configure email alerts when there are significant changes to the answers in a dashboard.
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Add to dashboard
Product Information: LYTGOBI (Futibatinib)
Based on the information provided in the table, here's a summary of the feedback and key insights about the product LYTGOBI (Futibatinib):
Efficacy
1. Good response rates and long duration of response:
Patients have shown responses lasting >2 years
Good efficacy reported, making it a go-to option for FGFR2 fusion or gene rearrangement
Exciting response rate and longer duration of response
PFS is longer than anticipated
2. Potential for use in specific patient populations:
• May be used immediately after first-line treatment in patients unable to tolerate Cisplatin
Safety and Adverse Events
1. Nail toxicities:
Case studies
See A79 in Action
Discover how A79 is driving measurable productivity improvements for our partners
The platform's AI-powered insights allow us to tailor our medical communications and deliver the right information to the right audience at the right time. This has significantly improved our engagement and strengthened our relationships with key opinion leaders.
Head of Medical Affairs
Leading Pharmaceutical Company
A79 has been a true partner in our AI journey, working hand-in-hand with us to build custom solutions that are not only powerful but also incredibly user-friendly. The platform has been enthusiastically embraced by our entire team.
Head of AI development
Leading Oncology Company
A79 has completely transformed my workflow. I can now access critical scientific information, prepare for HCP interactions, and generate insightful reports in a fraction of the time it used to take.
Senior MSL
Top 20 Pharma
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