AmpleLogic RIMS

Regulatory Information Management System

Empower Your Regulatory Journey with AmpleLogic RIMS

Optimize Your Regulatory Workflow with AmpleLogic RIMS

AmpleLogic RIMS is a purpose-built Regulatory Information Management System (RIMS) designed to centralize and streamline regulatory filings and compliance processes across diverse industries, including Biologics, Medical Devices, CDMO, Chemical Industry, Contract Manufacturing, Generics, General Manufacturing, Contract Research Organizations (CRO), and Food & Beverages.

Efficient Lifecycle Management

Navigate the complexities of Regulatory Information Management effortlessly.

Redundancy Reduction

Wave off manual efforts and experience streamlined efficiency

User-Friendly Interface

Experience intuitive and user-friendly interface for simplified report submissions

Dynamic Compliance

Adapt seamlessly to the evolving regulatory landscape

This powerful solution simplifies and automates critical tasks, from product registration to timely application submissions, ensuring organizations maintain seamless compliance and minimize errors. With real-time notifications, role-based access, and automated workflows, AmpleLogic RIMS reduces manual workloads, enabling faster approvals and centralized control over all regulatory activities. Tailored to meet the exact needs of regulated industries, our RIMS solution drives operational efficiency, cuts costs, and helps businesses stay audit-ready and compliant with evolving industry standards.

Regulatory Submission Tracking

Monitor submission progress with automated tracking features, reducing manual follow-ups

Commitment & Variation Management

Effectively manage commitments, product variations, and regulatory obligations with tracking tools

Why Choose AmpleLogic RIMS?

AmpleLogic Regulatory Information Management System distinguishes itself as a premier system optimising regulatory activities from product inception to market launch. With features like regulatory submission tracking and validation, change control management, graphical report generation, our software eliminates manual work and ensures adherence to worldwide regulatory standards like 21 CFR Part 11 and EU Annex 11.

Streamlines operations

Simplifies regulatory compliance and enhances efficiency

Integration capabilities

Seamless integration for data exchange and data consistency

Compliance Assurance

Minimize compliance risks and reduce wastage

Electronic Authentication

Accomplish regulatory mandates with e-signatures and audit trails

Seamless Compliance and Precision with AmpleLogic RIMS

Managing regulatory information manually is often error-prone, time-consuming, and expensive—posing significant challenges, from missed regulatory deadlines to disjointed team collaboration and compliance risks. AmpleLogic’s Regulatory Information Management System (RIMS) directly addresses these pain points by simplifying the submission process and ensuring accuracy through automation, thereby reducing compliance risks. With enhanced features like automated reminders for regulatory commitments, central database access from anywhere, and efficient tracking, our RIMS solution enables faster submissions, lowers costs, minimizes wastage, and boosts productivity. The system’s robust platform promotes collaboration and data integrity, ensuring you remain audit-ready and compliant, while empowering teams to focus on core objectives.

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Effortless Compliance,
Elevated Efficiency

AmpleLogic RIMS offers a comprehensive set of features to enhance efficiency and collaboration, including

Tracking and Publishing of Submissions

Ability to monitor, track, and publish regulatory submissions efficiently within the system.

Reviewing Submissions

Dedicated feature for systematic review of submissions before finalizing them for compliance

Approval and Rejection Monitoring

Real-time tracking of approval or rejection status for each submission to streamline decision-making

FDA Target Date Notifications

Specific notifications for FDA target dates to ensure timely compliance with critical regulatory deadlines

Product Registration

Collect and manage product registration information seamlessly

Superb Authentication

Validate records with e-signatures, timestamps and role-based access

Submission Validation

Ensures compliance and technical accuracy of documents prior to regulatory submissions

Automatic Notifications for Critical Dates

Receive timely alerts for FDA target dates and other key compliance milestones, ensuring timely submissions and responses

Submission Tracking

Efficient monitoring of submission status of regulatory documents

Cost Reduction

Cut expenses and boost overall productivity

Submission Preparation & Management

Create, track, review, and publish submissions easily. Monitor approvals and rejections in real-time.

Change Control Management

Tracks and regulates alterations made to regulatory documents, ensuring traceability throughout the document lifecycle

Graphical Reports

Provides interactive graphical reports in regulatory documents for easier analysis and decision-making

Real-time Notifications

Receive email notifications for regulatory commitments

Product Registration Tracking

Easily collect and update product registration information for accurate, up-to-date regulatory reporting

Targeted Date Alerts

RIMS notifies users of approaching regulatory deadlines

Centralized Database

Access central database from anywhere for streamlined information retrieval

Vendor Management

Oversees and coordinates interactions with third party vendors to ensure compliance with regulatory requirements

Product Lifecycle Management

Manages product development lifecycle through regulatory approval and market release

Cross-Industry Compatibility

Benefit various industries including lifesciences, food & beverages, cosmetics, etc

Workflow automation

Automate repetitive regulatory processes for faster turnaround times and reduced compliance risks

Audit Trials

Audit trials for keeping record of system modifications, upholding accountability, regulatory compliance, and aiding forensic inquiries

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Unlock Excellence

A Journey Through AmpleLogic RIMS Integrated Modules

Amplelogic RIMS

Frequently Asked Questions

RIMS is a Regulatory Information Management System designed to streamline and simplify the product application and registration lifecycle in various industries.

AmpleLogic RIMS reduces manual efforts, eliminates redundancy, and offers a user-friendly interface, resulting in increased efficiency in regulatory processes.

AmpleLogic RIMS adheres to electronic record requirements established by regulatory authorities worldwide, including TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, and KFDA.

AmpleLogic RIMS caters to industries such as pharmaceuticals, biotechnology, medical devices, food & beverages, and more.

Yes, AmpleLogic RIMS is scalable and adaptable, catering to the needs of businesses of all sizes – from small to large enterprises.

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