Regulatory Information Management (RIMs)

Efficiently Manage Regulatory Data Across the Product Lifecycle

Regulatory Information Management (RIM) is essential for pharmaceutical, healthcare, and medical device companies to efficiently handle regulatory submissions, compliance, and approvals. Our RIM system allows for seamless tracking, document storage, and submission management, ensuring you meet evolving regulatory requirements without delays.

Key Features of Our RIM System:

Centralized Regulatory Data Management: Keep all compliance documents organized in one system.
Automated Workflows & Version Control: Ensure consistency and accuracy across all submissions.
Real-Time Tracking & Audit Trails: Monitor submission status and regulatory interactions.
Seamless Integration with eCTD: A unified approach to managing compliance and lifecycle updates.

By implementing RIM solutions, companies can streamline regulatory processes, reduce risks, and improve overall compliance management.

Pharmaceutical consultant discussing the strategy and report with a client

electronic Common Technical Document (eCTD)

eCTD Publishing & Regulatory Submissions

Simplify Compliance with Expert eCTD Services

Managing electronic Common Technical Document (eCTD) submissions can be complex, but our streamlined services ensure compliance, accuracy, and efficiency. MC Pharma offers end-to-end eCTD publishing and e-submission solutions, helping you navigate regulatory requirements with ease. Whether submitting to SAHPRA, BoMRA, NMRA, or other authorities, we ensure seamless document preparation, validation, and lifecycle management.

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Key Benefits of eCTD Implementation

Faster Approvals, Improved Compliance, and Cost Savings

01. Improved Efficiency & Automation

Streamlines regulatory submissions with automated workflows, reducing manual workload and errors.

02. Regulatory Compliance & Validation

Ensures submissions meet SAHPRA, BoMRA, NMRA, and global regulatory standards with built-in compliance checks.

03. Better Document Organisation

Standardised eCTD structure simplifies document management, tracking, and version control.

04. Enhanced Collaboration

Centralised data allows seamless communication between teams, regulatory agencies, and stakeholders.

05. Cost & Time Savings

Eliminates printing, shipping, and administrative costs while accelerating regulatory approvals.

06. Transparency & Audit Readiness

Maintains a clear submission history and audit trails for compliance reviews.

07. Scalability & Flexibility

Easily manage large and complex dossiers while adapting to changing regulatory requirements.

08. Real-Time Tracking & Monitoring

Provides instant updates on submission status, approvals, and compliance progress.

09. Global Regulatory Alignment

Harmonised submissions support market expansion and faster approvals in multiple regions.

10. Faster Time-to-Market

Reduces approval timelines, helping companies launch products more quickly and gain a competitive edge.