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
Frequently Asked Questions
What is AmpleLogic RIMS?
AmpleLogic RIMS is a Regulatory Information Management System designed to streamline and simplify the product application and registration lifecycle in various industries.
How does AmpleLogic RIMS improve efficiency?
AmpleLogic RIMS reduces manual efforts, eliminates redundancy, and offers a user-friendly interface, resulting in increased efficiency in regulatory processes.
How does AmpleLogic RIMS comply with global regulatory standards?
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.
What industries can benefit from AmpleLogic RIMS?
AmpleLogic RIMS caters to industries such as pharmaceuticals, biotechnology, medical devices, food & beverages, and more.
Is AmpleLogic RIMS scalable for different business sizes?
Yes, AmpleLogic RIMS is scalable and adaptable, catering to the needs of businesses of all sizes – from small to large enterprises.
Contact us
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:
Your benefits:
- Client-oriented
- Independent
- Competent
- Results-driven
- Problem-solving
- Transparent
What happens next?
1
Schedule a call at your convenienceÂ
2
Discovery and consultation session
3
Get your custom proposal