The Samarind RMS suite is a fully integrated software solution that has been purpose built to mirror the processes associated with acquiring and maintaining product licenses.

Samarind RMS provides a smarter way to manage your Medical Product Information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality.

Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system.

Our features include:

  • A secure Regulatory Information Management (RIM) system with planning, tracking, automated alerts and comprehensive reporting facilities
  • An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™
  • An optional eCTD module for dossier creation and maintenance (VNeeS & NeeS are also supported)
  • An optional EVMPD module for automated maintenance of data required by the EMA’s extended medicinal product dictionary, XEVMPD with a clear roadmap for IDMP
  • A Med Info addition, for quick and easy logging of medical information queries, with links to the associated products elsewhere in the system as necessary
  • Medical device registration solution with project management support and FDA UDI generation
  • A Drug Safety module, handling Pharmacovigilance requirements
  • Project Management Solution, a managers tool linking your tasks & data

Key Benefits

  • Increased administrative efficiency, allowing timely response to critical deadlines
  • Improved global regulatory communications via information sharing through the medicinal product life cycle
  • Improved product launch planning, helping to maximise product revenue
  • Transparency of global licensing activities and current status, keeping tight and timely product control
  • Greater security of license data, supporting better information control
  • Increased compliance via secure access, audited activities and permissions
  • Reduced global product portfolio maintenance costs via single data entry, extensive reporting and alerts
  • Maximizes the potential earnings of your licenses

Samarind RMS Solution Overview



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Samarind RMS Overview
RIM for Medical Devices
RIM for Generics
RIM for Drug Safety

Regulatory Information Management

The core of Samarind RMS is its regulatory information management database. This has been carefully structured to allow you to accurately record and maintain all your medicinal product information throughout its lifecycle.

The Samarind RMS Windows software application provides the security, flexibility and ease of use that your regulatory affairs team needs to meet its regulatory and commercial obligations.

  • At-a-glance visibility of all the products in your portfolio;
  • A secure central repository of all your product documentation, from SmPCs and PILs to PSURs and business contracts ;
  • Sophisticated administrator-configurable role-based user permissions, for flexible security;
  • Event tracking for drug licensing applications, variations, PSURs and renewals;
  • Record information about key partners e.g. API manufacturers and QC Testing sites;
  • Time stamped historical audit of all previous submissions and variations;
  • Dashboard KPI's & system generated alerts at key stages;
  • All data is contained within the same SQL database for security, robustness and performance;
  • Extremely flexible and user friendly search and reporting facilities.

Fact Sheet

Fact Sheet

Medical Devices

Medical Devices

Historically, Regulatory Professionals within the Medical Device community have not had access to software solutions designed to meet their specific needs. Tracking data across multiple spreadsheets and cross-referencing files in document management systems was cumbersome, complicated and costly. Until now, the solutions available to Regulatory Professionals addressed just a small section of regulatory functions and as a result either supported a few industry needs or required large investments to make them fit for purpose.

Accessed online or installed on-site, the Samarind RMS Medical Device Software Solution offers a more intelligent approach. Samarind RMS provides the most efficient, practical and cost-effective way to manage all regulatory information in one place.

Practical features that produce powerful results

Reduce the time to agency submission and approval

Reduce the costs and delays in managing global registrations

Improve quality and compliance with global regulations

Access real-time regulatory data on products and registrations

Leverage regulatory information as a corporate asset

Enable reporting on key performance metrics

Drive cross-functional product change management

Minimize resource spent on data verification and remediation

Improve information exchange with MDM, ERP, PLM and EDMS

A comprehensive set of features, delivered through an intuitive software solution, help our customers more easily manage the full spectrum of regulatory activities needed to support the entire lifecycle, from product Concept through to Obsolescence.

Our pragmatic single-place-of-truth™ approach to systems design and implementation means that Instem customers can manage their products and registrations smoothly and efficiently, safe in the knowledge that at all times, they have access to real-time, accurate regulatory data.

Regulatory insight is now literally just a click away.

Samarind RMS is well known across the Medical Device industry as a high quality, sophisticated, user-friendly and well-architected solution. Every day, customers around the world use our solution knowing that they are supported by a level of customer service that is setting a new benchmark for client satisfaction.

The Samarind RMS Medical Device Solution provides

A secure Regulatory Information Management system that supports regulatory activities across all stages of the product lifecycle

  • An electronic document management system (EDMS) for submission content and dossier management with version control and template management capabilities
  • Support for regulatory authority interactions and change management through project planning and management tools, with automated notifications, alerts and dashboards
  • Global product and facilities registration and notification management.
  • Support for data and information exchange including UDI management
  • Management of Facilities and Economic Operators and their relationships to products and registrations
  • Regulatory impact assessment through user-defined queries and reporting capabilities enabled by managing relationships between regulatory data and documents across products and regional registrations
  • Project Management Solution, a manager’s tool linking your projects, tasks & data
  • Ability to link to external document management systems such as Documentum™ or SharePoint™ and exchange information with PLM and ERP systems
  • Interactive analytical tools that report performance metrics, accelerate decision making and enable strategic management of a world-wide market for multiple products
  • For businesses with pharmaceutical or combination products, a single system for both drug and medical device data
  • Easily deployed as a traditional on-site solution or via SaaS
  • Tailored implementation programs to suit companies of all sizes, including access to dedicated application and industry specialists and extended customer care
Generics

Generics

Samarind RMS provides a smarter way to manage your Medical Product Information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality.

Our features include:

  • A secure Regulatory Information Management (RIM) system with planning, tracking, automated alerts and comprehensive reporting facilities
  • An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™
  • An optional eCTD module for dossier creation and maintenance (VNeeS & NeeS are also supported)
  • An optional EVMPD module for automated maintenance of data required by the EMA’s extended medicinal product dictionary, xEVMPD with a clear roadmap for IDMP
  • A Med Info addition, for quick and easy logging of medical information queries, with links to the associated products elsewhere in the system as necessary
  • Medical device registration solution with project management support and FDA UDI generation
  • A Drug Safety module, handling Pharmacovigilance requirements
  • Project Management Solution, a managers tool linking your tasks & data
  • Offered as a traditional on-site solution or through a subscription to the Instem Cloud (SaaS)

Key Benefits

Lowers cost of ownership

Simplifies regulatory management

All key regulatory functions now together in one integrated place

Efficiency savings through managing pharmaceuticals, veterinary products and medical devices in one system

Cost effective system that scales as your business grows

Enables the tracking and management of large numbers of products

Significantly reduces the risk of missing regulatory activities and deadlines

Maximizes the potential earnings of your licenses

Drug Safety

Drug Safety

The Samarind RMS Drug Safety Solution offers one of the most efficient and practical ways to manage all business-critical pharmacovigilance activities from within a single environment. Today’s Regulatory Affairs Specialists are now accessing, processing and analyzing all of their regulatory data in one place, with complete confidence.

Key capabilities include:

  • Heightened Compliance
  • Reduced efforts with full MedDRA integration combined with bulk version updates
  • Secure tracking and audit trailing of developing cases for 21 CFR Part 11 compliance
  • Full history of developing situations
  • Maintains a full record of regulatory communications including ICSR XML messages
  • Heightened efficiencies
  • Integrated product, license & safety information reduces time and errors
  • Visibility and processing of master cases and their related cases
  • Integrated electronic document control
  • Personalized task lists to help avoid costly oversights
  • Better Controls
  • Integrate product, license and safety data for easier trend identification
  • Faster decision making abilities with real time analytics
  • Powerful yet intuitive search, reporting and analytics

Our pragmatic approach to systems design and implementation means that our customers can manage their information smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system.

Key Benefits

Increased administrative efficiency, allowing timely response to critical deadlines

Improved global regulatory communications

Improved planning and optimization of current staff resources

Transparency of global activities and current status, keeping tight and timely control of all milestones and deadlines

Greater security of critical data, supporting better information control

Increased compliance via secure access, audited activities and permissions

Reduce costs through single data entry, extensive reporting and alerts

Virtual Demonstrations

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Virtual Demonstrations

To help you evaluate systems, we believe that an initial, no-pressure demonstration carried out over the Internet is the way to go.

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