AI Tool

Streamline Your Regulatory Submissions

Effortless management of health authority filings with Certara's Regulatory Information Management.

Maximize efficiency with structured authoring and tracking.Ensure compliance with up-to-date regulatory standards.Accelerate your submission process with seamless integration.

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overview

Overview of Certara Regulatory Information Management

Certara's Regulatory Information Management tool revolutionizes the way life sciences companies handle their regulatory submissions. Our platform facilitates structured authoring, precise tracking, and streamlined publishing to health authorities, ensuring that your filings are always up-to-date and compliant.

  • Designed specifically for the life sciences industry.
  • Enhances collaboration among cross-functional teams.
  • Reduces time spent on manual submission processes.

features

Key Features

Our tool is equipped with advanced features that simplify the regulatory submission process. From comprehensive document management to real-time collaboration capabilities, Certara enhances your team's productivity.

  • Structured authoring that maintains consistency.
  • Automated tracking of submission progress.
  • Flexible publishing options tailored to regulatory needs.

use_cases

Use Cases

Whether you're preparing a new drug application or managing ongoing submissions, Certara's Regulatory Information Management tool addresses a diverse range of use cases. Enhance your workflow and minimize risks with our comprehensive solutions.

  • Support for IND, NDA, and BLA submissions.
  • Management of complex clinical trial documentation.
  • Facilitate submission updates and amendments effortlessly.

Frequently Asked Questions

What is Certara Regulatory Information Management?

Certara Regulatory Information Management is a specialized tool designed for life sciences companies to manage health authority filings efficiently, providing features for structured authoring, tracking, and publishing.

How does this tool improve submission processes?

The tool improves submission processes by automating documentation, tracking progress in real-time, and ensuring compliance with regulatory standards, ultimately saving time and resources.

Is training available for new users?

Yes, Certara offers comprehensive training and resources for new users to ensure they can effectively utilize the Regulatory Information Management tool.

Streamline Your Regulatory Submissions | Certara Regulatory Information Management | Stork.AI