Amplexor: streamlined regulatory information management

Life Sciences companies of all sizes need to optimize efficiency and reduce overheads, which can most effectively be achieved by leveraging their data to make them more accessible, connected and actionable to enable smarter, faster decision-making. Unfortunately, most companies are not in a position to utilize their data because they lack proper visibility and accuracy while data is generated in such huge volumes that making it useful is a challenge. Much of the time, companies struggle with disconnected, duplicated and often inaccurate data, causing bottlenecks and adding unnecessary cost. At the same time, the regulatory and business environment in the Life Sciences industry is complex and continuously evolving.

Reducing this complexity while improving data quality is a critical step to simplify compliance processes in global markets.

To meet these needs, Amplexor offers its constantly evolving holistic RIM platform for regulatory information management. This offers a streamlined approach, helping life sciences companies achieve long term business benefits beyond mere compliance, and enabling them to manage data more effectively and efficiently, allowing them to plan ahead, make informed decisions, save time and streamline their regulatory processes.

Amplexor RIM benefits

The Amplexor RIM Platform offers the following benefits:

• A holistic solution, which supports end-to-end business processes
• A common, centralized master data model, which provides a solid foundation for a single source of truth
• Powerful automations, which minimize manual steps and data entry, while improving data quality
• Reusable data and content across all solutions and processes
• Increased enterprise-wide efficiency, standardization and collaboration
• Lower complexity, higher overall quality of data, and sustainable compliance

RIM platform applications

The RIM Platform provides businesses with the tools to:

• Manage product information throughout the products lifecycle
• Plan and track regulatory applications and activities
• Manage all interactions with health authorities and other regulatory bodies
• Oversee the authoring, review and approval of submission documents
• Plan, compile, review, publish, submit and manage submissions
• Support global label management processes
• Manage product data and content in line with the IDMP target operating model (TOM)

Amplexor RIM Products

The RIM platform is part of the Amplexor Life Sciences Suite that consists of a series of modules that can operate as stand-alone solutions or in conjunction. These include:

• ProductExpert™: This addresses Product Information Management (PIM) needs for planning, collection, management and submission of structured product data throughout the submission lifecycle, post-submission, and post-approval, following the IDMP target operating model according to stringent compliance and quality standards. Product information management is a seamless part of the end-to-end RIM experience.
• RIMExpert™: A powerful regulatory planning, tracking and reporting solution designed to standardize the data management process across your entire company. It provides a new, intuitive compliance structure with no double data entry, no extra effort and no time wasted, enabling a clearer picture for planning and scheduling, while seamlessly connecting to IDMP, eCTD and content management solutions for faster time to market.
• R&DExpert™: This module promotes cross-functional collaboration in Regulatory Content Management (RCM) by establishing a single authoritative document asset repository, covering all document management functionalities, including template management, collaborative editing, annotations and hyperlinking, flexible workflows, electronic signature and audit trail, advanced rendering, compound documents and role-based security.
• SubmissionExpert™: Consolidates submission management and publishing capabilities within one unique solution. Leveraging built-in regulatory intelligence, it enables product information driven global and local submission content planning, submission pre-validation and publishing according to regional standards in eCTD, NeeS, PDF or EAEU format as well as versatile submission archive.
• LabelExpert™: Focuses on the end-to-end labeling management process as well as activities such as the assessment, revision, approval, tracking and implementation of labeling changes, seamlessly connected with Regulatory Planning & Tracking as well as RCM capabilities.
• RIMAnalytics™, ProductAnalytics™, SubmissionAnalytics™ and LabelAnalytics™: These modules provide a series of preconfigured sets of standard dashboards and reports as well as self-service analytics, meeting business tracking, reporting and analytical needs.

Resources

Click on Regulatory Information Management for further information.