Product Overview
Agatha’s eRegulatory application stands as a regulatory document management software powerhouse, efficiently collating and managing all necessary information for regulatory submissions. Transform your regulatory operation with Agatha’s regulatory submission software.
Revolutionize your regulatory approval process with our regulatory submission software
Achieving regulatory approval is the cornerstone for marketing new drugs, devices, and therapies. Ensure success with our regulatory submission software – a critical tool in expediting regulatory operations and processes, and avoiding costly errors.
Regulatory submission software for streamlined regulatory process management
Agatha’s regulatory submission software, designed for pharmaceutical companies, provides an all-encompassing regulatory document management software solution. It efficiently compiles submission content, even when created by different teams across various locations.
Agatha’s regulatory document management software: Your path to FDA compliance
Use our regulatory document management software to gather and manage regulatory documents from all clinical trial sites. Prioritize regulatory review and submission with our organized and comprehensive software solution.
Agatha’s regulatory submission software: Driving the submission process forward
Experience our regulatory submission software features, such as tracking applications, streamlining eCTD submissions, and integrating with other software products. Take advantage of our free trial for your clinical trials to discover the power of our regulatory document management software.
Agatha’s regulatory document management software: Going above and beyond industry standards
Our regulatory document management software offers unique features, such as simultaneous online document review and automatic identification of missing submission items, elevating the quality of your dossier management and eliminating manual processes
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
The role of regulatory document management software in regulatory compliance
A regulatory information management system (RIM system), such as Agatha’s regulatory document management software, accelerates regulatory compliance processes and ensures compliance with regulatory bodies. It offers a unified platform for managing regulatory documents and preparing standardized submission documents in regulated formats.
Tasks performed by Agatha Regulatory
- Identifies the products required for international regulatory agencies;
- Collects technical documents such as Electronic Common Technical Documents (eCTDs);
- Controls the access to documents when dealing with different products and regulatory agencies;
- Manages changes and revisions to documents and products;
- Generates compliant submission documents;
- Enables electronic signatures of study documents;
- Issues and track submissions across the paper and through the appropriate gateways;
- Minimizes effort and calendar time for companies to replicate regulatory submissions between products and regulatory authorities;
- Ensures that original content is submitted on time and correctly;
- Fulfills regulatory requirement for electronic equipment, such as 21 CFR Part 11;
About the company
Virtually all clinical and compliance solutions are based on traditional document management approaches. You know, check-in, check-out, yada yada. Agatha breaks the mold with better technologies to deliver a solution to manage end-to-end processes, not just documents. Agatha’s founders, saw firsthand that clinical and compliance solutions available in the market are built on excessively complex platforms and took far too long to bring to productive use. Lead times for implementing these unwieldy and costly systems are often as long as six months.
Clinical trials and compliance processes are the bridge between developing new drugs, devices, and therapies and getting them to the patients who desperately need them. Every day managing trials and compliance activities mean another day before a new drug or treatment is available to patients.
They set out to prove that a new class of cloud-first, ready-to-use applications could shorten the time required to get critical new drugs and treatments to patients.
