Driving Digital Innovation in Regulatory Submissions with Navitas Life Sciences

The pharmaceutical industry is undergoing a significant transformation driven by digital innovation and artificial intelligence (AI). It has become increasingly beneficial to leverage AI powered tools and cloud based regulatory solutions to streamline regulatory submissions. These advancements enhance efficiency, improve data exchange, and ensure compliance with health authority expectations.

The Multitenant Model: Enabling Seamless Regulatory Submissions

What is Multitenancy?

A multitenant platform offers a transformative approach to document sharing and archiving. Unlike traditional systems, this model allows multiple clients or tenants to operate within a shared environment while maintaining strict data segregation. Each sponsor, regulatory service provider, and reviewer accesses only the relevant, authorized data, ensuring confidentiality and compliance.

Beyond security, the multitenant model fosters enhanced collaboration between sponsors and service providers. The COVID-19 pandemic highlighted the need for secure, real-time data exchange between regulatory authorities and industry stakeholders to accelerate approvals. In regulatory affairs, where work-sharing and reliance models are gaining traction, this architecture streamlines information exchange, reducing redundancy and improving decision-making timelines.

Regulatory as a Service (RaaS): A Cloud-Based Framework for Regulatory Success

Regulatory as a Service (RaaS) provides a dynamic and cost-effective solution for managing regulatory workflows. By integrating AI and automation within a multitenant cloud infrastructure, RaaS ensures resource availability, dedicated point of contact assigned at the outset, effective communication, Regulatory Intelligence, efficient document life cycle management, submission tracking, and workload distribution. This approach enables:

• Automated publishing tasks to improve submission accuracy and timeliness.
• Regulatory information management for real-time tracking and compliance.
• Label and artwork lifecycle tracking to streamline global product management.
• Interlinked document management with regulatory publishing tools to facilitate seamless collaboration.
• Individual User Accounts and Secure Document Management

Regulatory agencies worldwide are actively adopting digital modernization strategies to enhance IT capabilities, data management, and advanced analytics. The FDA’s Technology and Data Modernization Action Plan serves as a prime example, demonstrating the agency’s commitment to leveraging digital advancements for improved regulatory oversight.

regulatoryREADY: Providing a Single Source of Truth

regulatoryREADY serves as a comprehensive, integrated solution designed to streamline regulatory processes through seamless collaboration between flagship and partner technologies. By offering a single source of truth, it enhances efficiency and compliance across critical regulatory functions.

From RIMS for product registration and marketing applications to Regulatory Strategy & Intelligence for informed decision-making, the platform supports the entire regulatory lifecycle. IDMP ensures enterprise-wide data harmonization, while DMS/Multitenant simplifies document preparation, collaboration, and change control.

eCTD/SPL/Build & Automation optimizes submission processes with built-in validation and automation, significantly reducing errors and submission timelines. Labeling & Artwork management ensures seamless global and local updates, enabling faster market rollouts.

By integrating these capabilities, regulatoryREADY empowers life sciences companies with a smarter, more agile regulatory framework. Pharma and Biotechs should utlise this system to accelerate their growth.

Overcoming Challenges with the Right Partner

While multi-tenancy offers significant advantages, organizations must carefully address security, performance isolation, and compliance requirements. Advanced techniques such as containerization, data partitioning, and tenant-specific encryption help ensure that one tenant's activities do not impact others.

As a cornerstone of modern cloud computing, multitenancy enables businesses to access cost-effective and scalable applications. With the continued growth of cloud adoption, multitenancy will remain a key enabler of digital transformation, helping enterprises achieve greater efficiency and innovation.

Partnering with an experienced regulatory submissions provider can further enhance submission timelines and operational efficiency. By leveraging a structured approach to multi-tenancy, Navitas Life Sciences can drive efficiency and enhance regulatory compliance.

Article

AI and Digital Technology in Regulatory Submissions

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Authors

Mallikaarjunan R

Senior Vice President
Regulatory Affairs & Technology

Prasana Santhuru

Team Lead
Regulatory Services

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