AmpleLogic RIMS

Regulatory Information Management System

Empower Your Regulatory Journey with AmpleLogic RIMS

Optimize Your Regulatory Workflow with AmpleLogic RIMS

Pharmaceutical companies face challenges in managing regulatory information due to evolving standards, fragmented data, and the risk of compliance failures, which can lead to penalties, delays, or recalls. Many Regulatory Information Management Systems (RIMS) still rely on manual processes, increasing the chances of errors and delays. As companies grow, scaling RIMS to manage increasing data volumes and maintain audit readiness becomes crucial.

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

AmpleLogic’s AI-powered RIMS solution transforms this process by automating compliance tracking, ensuring alignment with changing standards, and centralizing data for easy access and updates. The AI uses predictive analytics to identify and mitigate risks, automates manual tasks, and reduces errors, accelerating reporting and meeting deadlines. Scalable and efficient, the solution adapts to business growth, ensuring audit readiness and minimizing operational costs, helping companies stay compliant while driving innovation.

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

Challenges Tracking Pharmaceutical Regulatory Information

Complex and Evolving Regulations

The pharmaceutical industry is governed by complex and frequently changing regulations, both at local and global levels. Keeping up with these changes is time-consuming and difficult

Scalability

As companies grow, regulatory data volume and complexity increase, demanding scalable systems that adapt to evolving requirements and support expanding business needs.

Compliance Risks

Non-compliance can result in significant penalties, delays, and reputational damage. Ensuring that all regulatory requirements are met across different regions is a constant challenge

Manual Processes

Many organizations still rely on manual processes for tracking and managing regulatory data, which increases the risk of human error, delays, and missed updates

Data Security and Privacy

Regulatory data must be protected from unauthorized access and breaches, which can be a challenge when dealing with large volumes of sensitive information

Audit Readiness

Keeping regulatory documentation organized, up-to-date, and ready for audits requires significant effort and resources, especially during inspections

Switch to AmpleLogic AI RIMS Solution

AmpleLogic AI-powered RIMS automates regulatory tasks, ensures compliance, accelerates approvals, and provides audit-ready reports. Compliant with 21 CFR Part 11 and EU Annex 11, it enhances efficiency, reduces costs, and optimizes the regulatory process from start to launch.

Effortless Compliance, Elevated Efficiency

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

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Compliance Tracking
AI continuously monitors and adapts to evolving local and global regulatory standards, automatically updating processes to ensure compliance without manual intervention
Predictive Analytics
Leveraging AI, the solution analyses historical and real-time data to identify potential risks and compliance gaps before they escalate, helping to proactively mitigate issues and avoid penalties
Reporting & Documentation
AI automates the generation of regulatory reports and documentation, ensuring they are accurate, timely, and audit-ready with minimal human involvement
Risk Mitigation
AI-powered algorithms assess data patterns to flag potential compliance risks, offering predictive insights and recommending corrective actions to prevent problems before they arise
Regulatory Change Management
AI tracks and processes regulatory changes in real time, automatically implementing them into your systems to ensure ongoing compliance with the latest standards
Enhanced Efficiency
AI optimizes workflows, minimizing operational costs, speeding up regulatory processes, and ensuring consistent compliance across all levels of your business
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
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
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

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

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Life Sciences

Benefit from GMP solutions customized for life sciences, Pharma, R&D, biotech etc.

Food & Beverages

Enhance food and beverage manufacturing with software for efficiency and operational agility.

Medical Devices

Transform the medical device industry with software that enhances compliance.

Cannabis

Enhance cannabis and tobacco manufacturing with advanced software for efficiency.

Gene Therapy

Transform gene therapy with advanced software for precision and efficiency.

Cosmetics

Boost cosmetics and beauty operations with innovative software for process optimization.

Unlock Excellence

A Journey Through AmpleLogic RIMS Integrated Modules

Amplelogic RIMS

Abbreviated New Drug Application (ANDA) Tracker

Effectively handle the entire lifecycle of ANDA submissions, ensuring timely compliance with regulatory requirements.

Drug Master File (DMF) Tracker

Manage the complete lifecycle of DMFs, from restricted correspondence to timely notifications of changes and occurrences.

Your Pharma Automation Starts Here

We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage: