GxP Intelligence
Ai Enhanced
Regulatory Framework
Intelligent
Regulatory Compliance
Solutions
Leverage Ai powered compliance models to improve regulatory compliance management.
Our AI transforms regulatory strategy, generating automated content tailored to your unique needs for accelerated time-to-market.
End-to-end compliance traceability throughout your product lifecycle drives consistency, ensuring your vision stays on track.
Cut time-to-compliance and speed time-to-market with our automated platform, liberating you to focus on innovation that matters.
Introducing GAiME
Selecting the optimal generative
Ai model for your business objectives just got easier with GAiME
-
the Generative Ai Model Evaluation framework.
Train your own
MedDevice GPT
Train your Ai model on FDA Regulations and your proprietary PLM data.
Prompt your model to identify patterns and relationships between regulations and regulatory strategy.
A unified platform
Generator
Our AI-powered tool quickly evaluates your PLM data, ranking smart compliance options to accelerate time-to-market without sacrificing regulatory assurance.
Composer
Let our tailored AI generate "80% complete" regulatory documentation adapted to your strategy, accelerating time-to-market by efficiently managing complex processes.
Tracer
Tracer's living traceability matrix effortlessly aligns regulations, documentation, and PLM data, enabling real-time impact analysis to ensure consistency throughout development.
Defender
Backed by meticulous tracing and alignment with regulations and strategy, Defender crafts precise responses to regulatory inquiries, fortifying compliance and empowering legal and compliance teams.
Drive up efficiency
while
driving down cost.
Get to Market faster.
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