AmpleLogic RIMS

Regulatory Information Management System

Empower Your Regulatory Journey with AmpleLogic RIMS

Maximize Efficiency with AmpleLogic RIMS

Experience the future of regulatory management with AmpleLogic RIMS software. A sophisticated system engineered to optimize product application and registration processes in pharmaceutical, biotech and cosmetics industries. Its real time notification, role-based access, and workflow automation features transform regulatory management with unparalleled efficiency and accuracy.

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

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

Commitment and Variation Management

Effectively manage commitments, variations, and obligations with ease

Electronic Authentication

Accomplish regulatory mandates with e-signatures and audit trails

Effortless Compliance,
Elevated Efficiency

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

Submission Preparation

Simplify the submission process with tracking, reviewing, and automatic notifications for important dates.

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

Compliance Assurance

Minimize compliance risks and reduce wastage

Submission Tracking

Efficient monitoring of submission status of regulatory documents

Cost Reduction

Cut expenses and boost overall productivity

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

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

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.

Hear From Our Customers

Paramita Sarkar Vice President, OCuSOFT

AmpleLogic understood the limitations we had as a growing organization. With the budget constraints we had, we couldn’t have been able to find a better, flexible and customizable partner than AmpleLogic. We appreciate the team.

OM Prakash Sule Vice President, Windlas

Windlas Biotech is committed for transparent Quality Management System and other records. "This is the reason we opted for part 11 compliant partner AmpleLogic. Great contribution by AmpleLogic team to make it Live in shortest possible time"

Georges Ibrahim CQO, Julphar

AmpleLogic’s QMS application has higher level of transparency and efficacy. It has helped us in tracking day to day quality processes to manage huge information and data and also have transparency in managing
complaints.

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: