Effortlessly Manage Regulatory Submissions and Deadlines

Regulatory Compliance Made Simple with AmpleLogic DMF Tracker

AmpleLogic DMF Tracker streamlines the management of regulatory submissions, tracking the entire lifecycle of applications, from initial submission to closure. With comprehensive features tailored for regulated industries, it ensures compliance with regulatory obligations and deadlines. By centralizing communication tracking and providing automated reminders, it enables efficient handling of customer inquiries and regulatory queries.

Key Features of AmpleLogic DMF Tracker

Controlled Correspondence Tracking

Controlled Correspondence Management for Regulatory Compliance

Customer Communication Management

Customer Communication Tracking for Effective Engagement

Deficiency and Supplement Tracking

Deficiency and Supplement Monitoring for Compliance Assurance

Change Control Management

Change Control Management for Seamless Updates and Compliance

PADER Reporting Integration

PADER Reporting Integration for Adverse Event Monitoring

Access Restrictions for Data Security

Access Restrictions Ensure Data Security and Compliance

Effective Checks

Conduct periodic reviews to assess CAPA effectiveness.

Comprehensive Reporting

Generate insightful reports for enhanced visibility and decision-making.

Benefits of Choosing AmpleLogic DMF Tracker

Effortless Access to All Regulatory Data, Streamlining Compliance Efforts

Timely Notifications Ensure Regulatory Compliance and Avoid Missed Deadlines

Clear Overview Enhances Decision-making, Improves Regulatory Compliance

Facilitates Efficient Claim Preparation, Enhancing Compliance and Productivity

Frequently Asked Questions

AmpleLogic DMF Tracker assists pharmaceutical and biotech companies in managing the lifecycle of regulatory submissions and meeting deadlines.

It tracks customer inquiries, amendment submissions, and final notifications, ensuring efficient communication management.

Yes, it can collect data from systems like change controls and adverse event complaints, facilitating comprehensive tracking.

It provides automated reminders for target and due dates, minimizing the risk of missing deadlines and regulatory commitments.

Access restrictions based on job responsibilities ensure data security, with regulatory users having full access while others have limited access.

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