Regulatory Information Management System (RIMS)

RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.

RIMS Solution

Organizational regulatory information efforts begin with drug development to drug registration and commercial launch. Multiple divisions within a company are required to gather the regulatory data information required to supervise all processes in manufacturing, registering, and launching the drug. This information includes the design profile, ideas, technical information or specifications, and prototypes (if any). Many organizations currently keep and handle these operations using spreadsheets and paper records.

International rules and data standards in GMP environments evolve regularly. When Regulatory Information Management is done manually, its efficiency could be compromised,  and this is a challenge for pharmaceutical, biotechnology, and other related industries. All material should be submitted electronically using a document management system as required by regulatory standards. Organizations must adopt new technologies to prepare ahead for future requirements.

AmpleLogic Regulatory Information Tracker is built on the LOW CODE PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.

ANDA Tracker

AmpleLogic ANDA (Abbreviated New Drug Application) monitoring software enables you to handle the whole life cycle of applications submitted to regulatory authorities, from controlled correspondence to notifying regulatory authorities on modifications and occurrences. ANDA submissions can be managed until the deadline by setting up early warning systems for dates when commitments must be met

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DMF Tracker

AmpleLogic DMF Tracker manages the whole lifecycle of regulatory applications, from restricted correspondence to notifying regulatory authorities on changes and occurrences. Submissions of DMFs (Drug Master Files) may be tracked until they are closed, with prior warnings on commitment dates.

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Key features of AmpleLogic Regulatory Information Management Solution (RIMS)

  • Submission Preparation
  • Tracking and publishing of submissions
  • Reviewing submissions
  • Submission of content
  • Approvals and rejections are monitored
  • Automatic notifications for FDA Target Dates and Other important dates
  • Product Registration
  • Collecting product registration information

The Advantages of Regulatory Information Management and Tracking Software

  • The submitting process is simplified
  • Enhances teamwork and accuracy
  • Ensures compliance risks are minimized
  • Reduces wastage
  • It cuts expenses
  • Boosts productivity
  • You will be notified through email of any regulatory commitments you have
  • Accessibility to a central database is allowed from anywhere

AmpleLogic’s RIMS Software is developed to automate processes, interface with existing or legacy systems, and foster interactions among departmental teams within a company. AmpleLogic Regulatory Information Management Software (RIMS) is a powerful and simple-to-use solution that increases cooperation while also speeding up and improving the accuracy of regulatory submission procedures.

Additionally, the Regulatory Information Tracker conforms with the electronic record requirements established by the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, and KFDA.

Other industries that can benefit from our Regulatory Filings Tracker include:

  • Biologics
  • Medical Devices
  • Contract Development and Manufacturing Organization (CDMO)
  • Chemical Industry
  • Contract Manufacturing
  • Generics
  • General Manufacturing
  • Contract Research Organization (CRO)
  • Food & Beverages

Do you need a simple and sophisticated Regulatory Information Management Software? With quick and effective real-time access to your information, the AmpleLogic RIMS Solution will significantly increase compliance. Please contact us if you’d like to learn more about how AmpleLogic RIMS Software may help your company.

Improve Quality. Increase Efficiency. Ensure Compliance.

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