Regulatory Information and Data Management

Transforming Regulatory Information into Intelligence

Regulatory Information Management (RIM) is evolving from being a simple repository to becoming a Single Source of Truth for product data elements. This transformation turns information into intelligence and ultimately into actionable insights.

Regulatory information is extensive and permeates across all functions within a life sciences organization. With ever-evolving regulatory requirements, it is crucial for organizations to effectively manage this business-critical information. An end-to-end regulatory solution must encompass submissions as well a product registration tracking and maintenance across regions, functions, and partners.

At Navitas Life Sciences we help translate data into reusable and reliable information throughout your organization. We support data migration from your existing systems using our innovative rimREADY^® tool, simplifying RIM operations and enabling accurate, fully-validated, and timely submissions.

Our data management services include:

Product Registration Data Management

Our centralized team expertly manages product registration data for global submissions. We cover all essential data elements, including XEVMPD (Extended EHR and Version Management for Product Data) and IDMP (Identification of Medicinal Products). With our support you can ensure accuracy and consistency across all of your product registration efforts.

Submission planning and Tracking Services

Navigating the complexities of regulatory submissions can be challenging. Our submission planning and tracking services provide global clients with the necessary tools and insights to effectively plan and manage their submissions. We help you stay organized, on schedule, and prepared for any regulatory challenges that may arise.

Label Management Services

We offer robust label management solutions that cater to both global (CCDS – Common Core Data Sheet) and local labeling requirements. Our services include the building and management of diverse labeling data and formats, ensuring compliance with regulatory standards while maintaining clarity and accuracy in product information.

Commitment Tracking Services

Keeping track of global regulatory commitments is crucial for compliance. Our commitment tracking services facilitate the monitoring and management of your obligations, ensuring that you meet all regulatory requirements. We provide you with the visibility and support needed to maintain compliance effectively.

Change Control Services

Our change control services enable you to track and close change control entries efficiently. We ensure that all changes are documented, assessed, and resolved in accordance with regulatory standards, minimizing risks and enhancing data integrity.

Gain the Navitas Life Sciences Edge

Visibility across all Regulatory Affairs functions

Comprehensive oversight throughout a product’s life cycle

Integration and tracking

Seamless integration and tracking of all regulatory information and activities through a single communication system

Stakeholder Co-ordination

Efficient co-ordination across all stakeholders

Centralized Data Management

Initiated from application and maintained throughout the submission life cycle

Insights harnessed from rimnet

Harnessing insights from our industry-leading network

8 Offices in 5 Countries

Including 4 delivery centers across the globe.

Navitas Life Sciences ensures your Regulatory Information Management is streamlined, compliant, and insightful, providing you with a single source of truth and significant edge in regulatory affairs.

BROCHURE

Achieving RIM excellence with rimREADY^®

Learn more about our innovative technology to simplify RIM operations and enable accurate and timely submissions

CASE STUDY

A strategic journey to RIM maturity

Learn how we successfully implemented a RIM system for a global mid-sized biotechnology company in the US

eBOOK

Achieving Excellence in Regulatory Information Management

Exploring leading practices in regulatory operations, promoting the adoption of innovative practices and technologies. It aims to enhance the efficiency of regulatory affairs, ultimately helping companies deliver medicines to patients more effectively.

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