Regulatory Operations: Data Management

What is a RIMS?

• A Regulatory Information Management System (RIMS) facilitates the submission of both human and veterinary medicinal products to regulatory agencies for marketing authorization.
• This invaluable software system aids in managing product dossiers and regulatory data, preparing submissions, and maintaining regulatory product information in the required formats.
• Despite the widespread adoption of RIMS by pharmaceutical companies, many still rely on manual data entry. In the current landscape, it´s imperative for RIMS to be capable of directly transmitting data to the EMA.
• Companies are now required to gather a larger volume of data at earlier stages, necessitating robust technological solutions to meet these demands.

What should an effective RIMS look like?

• Enables to quickly and accurately identify product information requested by regulatory agencies
• Collects product information under the eCTD specification
• Takes into account the variation of products in the different agencies when creating a record
• Correctly manages file changes and revisions, as well as product updates
• Generates documentation subject to be submitted according to standards
• Tracks all presentations and publications
• Reduces times to issue submission to Regulatory agencies
• Allows a clear monitoring from original submission during product life cycle
• Adapts to company needs in terms of data volume and size to be managed
• Complies with Regulatory requirements

Partners

WHY choose Asphalion for migration activities during RIMS implementation

• Regulatory Information Expertise: Asphalion possesses deep expertise in managing regulatory information, ensuring that RIMS implementation aligns with global regulatory standards.
• Streamlined Data Management: Our company provides solutions that streamline the management of regulatory data across the product lifecycle, enhancing efficiency and accuracy.
• Customized Integration: Asphalion tailors RIMS integration to client-specific systems and processes, facilitating a smooth incorporation with minimal operational disruption.
• Compliance Assurance: With a strong focus on compliance, Asphalion collaborates with vendors to ensures that the RIMS implementation meets all regional and international regulatory requirements.
• Technology Leadership: Asphalion stays at the forefront of technological advancements, offering clients cutting-edge RIMS solutions that provide a competitive advantage

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