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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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

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

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

Medical Devices

Medical Devices

The Samarind RMS Medical Device Solution offers one of the most efficient and practical ways to manage all of your device registration information in one place. Our proven, intuitive software has been designed to help our customers more easily manage their licenses with complete confidence.

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.

The Samarind RMS solution is well known in the marketplace as a high quality, sophisticated, user-friendly and well-architected application. Our solutions are in use every day by customers around the world and are supported by a level of customer service that is setting a new benchmark for client satisfaction within the life sciences.

Regulatory Standards – it’s what we do…

The Samarind RMS Solution leads the way on XEVMPD data management and processing as well as providing full support for the FDA’s UDI standard. Our unique database structure means that the transition to IDMP will be just that – a smooth transition.

Instem has been supplying world-leading solutions to the life science community for more than 30 years and is well versed in all aspects of regulatory data capture, reporting and management in support of the industry’s processes. As a stable publicly traded corporation, Instem’s trusted services and solutions are supporting drug developers, medical device organizations, contract laboratories, consultants, universities, government agencies and leading health institutes in their missions.

Once connected, always connected.

Once clients become proficient users, Instem becomes an extension of their business ensuring they receive the highest amount of value from our integrated software. Through our Relationship Managers and value-added support tools, clients have access to a wealth of resources and support so they stay focused on their science, not their software.

Our solutions work independently or together, all designed to help clients bring their life enhancing products to market faster.

Key Benefits

Fully integrated end-to-end management for marketed medical devices

Full electronic record of regulatory communications

Provides one “single place of truth” to manage all product registrations in all regions

More commercial insight due to availability of integrated global regulatory data for analysis

Supports multi-disciplinary, global product launches

Increased administrative efficiency from managing a single integrated set of licence & product data

Provides different risk classification schemes in each market

Integrated, secure EDMS with archiving capabilities

Delivers effective global management of product lines though powerful analytics

Our features of the Medical Device Solution includes:

  • Full product lifecycle management
  • Unique Device Identifier (FDA-UDI) management for handling any type of medical device
  • A secure Regulatory Information Management (RIM) system with planning, tracking, automated alerts and comprehensive reporting facilities
  • Ability to identify and coordinate project tasks and activities across the globe
  • Product registration and notification management; transmit UDI and paper submissions to regulators with the ability to track all interactions
  • Ability to exchange information with PLM systems
  • Tailored implementation programs; perfect for smaller clients with access to dedicated client specialists and extended customer care
  • Offered as a traditional on-site solution or through a subscription to the Instem Cloud
  • A single integrated database that is used by all of our (optional) integrated modules:
    • 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 eCTD module for dossier creation and maintenance
    • A Medical Information capability, for quick and easy logging of medical information queries
    • A Pharmacovigilance module to handle product safety information
    • For businesses with pharmaceutical products, a single system for both pharma and medical devices
    • Powerful analytical tools to enable strategic management of a world-wide market for multiple products
    • Project planning and management tools, dashboards to enable user to understand and execute on timely, priorities work tasks

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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