The Regulatory Affairs Professionals Society (RAPS) Convergence is a pivotal event for regulatory professionals worldwide. As we approach the highly anticipated conference, Navitas Life Sciences, a global leader in regulatory and clinical services, is gearing up to discuss its vast experience and dedication to innovation.
We had the privilege of sitting down with Govind Srinivasan, Senior VP-Business Partner, Regulatory & Safety Technology, and Mallikarjunan R, VP - Regulatory Services to discuss the specific challenges and opportunities facing regulatory professionals today, the global approach to regulatory services, and recent success stories that highlight Navitas Life Sciences' expertise in the field.
Join us as we explore the challenges, vision, and our solutions as we prepare to meet you with our expertise and industry leadership at RAPS 2023.
Senior VP-Business Partner,
Regulatory & Safety Technology
Tell us about Navitas Life Sciences
Navitas Life Sciences is a global CRO, headquartered in Princeton, NJ, with access to manage submissions across 100+ countries. Our team brings in extensive experience and cutting-edge technologies to ensure patient safety throughout the life cycle of drug development and maintenance.
We offer a flexible global delivery model to meet all sponsor’s needs, enhancing compliance and risk management. Our unique industry network forums, such as pvnet, & pvconnect, provide collaborative platforms for learning, benchmarking, and accessing industry insights.
Maintaining a regulatory Technology platform covering End-to-end regulatory requirements in-house can be expensive and challenging for many SMBs. How does Navitas address this issue with its recent bundled solution?
This is key to many SMB clients in this industry. Navitas Life Sciences is at the forefront of integrating reg Services with end-to-end regulatory technologies and managing costs.
In addition to being highly cost-effective, our bundled solution is extremely user-friendly. Clients can access our ready-to-use technology stack and reg services expertise with minimal resources.
This translates into reduced upfront costs and allows gradual scale-up of operating expenses as clients expand. Many clients have confirmed achieving significant cost reductions along with management of regulatory operations with ease.
Since Tech is bundled with reg Services, does the range of technology cover all aspects of Reg Services? Do the sponsors participate in the workflow and have direct access to all application components?
Navitas offers a full range of technology required for end-to-end Reg services to meet your unique needs. This tech stack covers the full scope starting from Document Management system, Publishing platform, eCTD, SPL, Labelling and artwork, license, regulatory strategy and Intelligence and IDMP, training records management.
Navitas Life Sciences promotes a one-team culture with its Sponsors and collaborates with all the stakeholders using technology instead of interfacing using emails (for example, The Document Management and Approval Workflows, and the review of submission files are carried out on the system). Therefore, all relevant client resources will have full access to the systems.
How does Navitas leverage AI/ML/NLP technologies to optimize costs and maintain quality as the volumes scale up?
Navitas Life Sciences invests significant R&D dollars in offering technology-enabled global Reg services by automating labor-intensive components using AI/ML/NLP technologies.
We successfully use these technologies in processing documents, structured as well as unstructured, pulling metadata from the systems so that we can support our customers in managing documents and submissions.
There is always a human in the loop in validating the automated processes and recording the verification to initiate the learning process.
How does Navitas enable standardization in reporting and processing safety events across multiple sources and trials conducted by multiple clinical research organizations (CROs)?
Standardization is pivotal for ensuring regulatory compliance and submissions. Navitas Life Sciences prioritizes in terms of establishing standards in terms of SOPS, how documents are shared, how documents are reviewed and approved and associated technology, so that we have standardization across multiple submissions. We also emphasize training for all stakeholders to ensure clear communication of expectations.
VP - Regulatory Services,
Navitas Life Sciences
What are specific challenges and opportunities that regulatory professionals face today?
In a constantly changing environment, regulatory professionals must be involved in every phase of developing, marketing and selling products. This necessitates a continuous commitment to learning, enabling effective collaboration with diverse regulatory colleagues and seamless communication with health authorities. Moreover, these professionals play a pivotal role in articulating the criticality of regulatory compliance in achieving organizational objectives. They bring strategic input to the clinical advancement of pharmaceutical products, possessing an acute understanding of regulatory prerequisites that streamline decision-making processes. Embracing technology for better outcomes and to gain efficiencies, especially in the use of AI & ML, will help reduce processes and accelerate the drug to market.
How does our global presence influence the way we approach regulatory services for clients across different regions?
Navitas Life Sciences has extensive global regulatory expertise, catering to small to large pharmaceutical companies. We excel in harnessing real-time insights and identifying future trends through our NET interactions.
We provide realistic global solutions with measured risk management, strong processes, prior track record, culture of ‘’Delivery first, everything else later’’, robust quality management processes. With a team of highly experienced professionals spanning the globe, Navitas Life Sciences is equipped with readily available resources, and they have well-defined plans for ramping up and recruiting additional personnel as needed. We have flexible options, designed to scale up or down in response to shifting business dynamics, with a range of technology options.
Navitas Life Sciences is distinguished by its commitment to innovative models and strategies, promising substantial advantages to clients, including heightened productivity and a continuous drive for improvement.
Are there any recent success stories or notable projects in the regulatory services domain that you'd like to highlight?
Recently we supported an IND submission for a mid-sized pharma, specializing in oncology and autoimmune diseases. We provided highly efficient protocol design & review by regulatory strategist, faster & efficient FDA Query responses, 100% conformance on timelines, parallel author & review of CTD sections using pharmaREADY® DMS, and transparent project management.
It resulted in
- 3 RFI (Request for Information)
- FDA acceptance within 3 weeks
What message would you like to convey to professionals who are considering attending RAPS Convergence and might be interested in learning more about Navitas Life Sciences?
We are one of the leading industry networks with vast expertise, making us uniquely positioned to provide you with the best possible flexible support for your regulatory needs. Our services cover a range of areas including Initial Submissions (IND, NDA, BLA, MAAs) spanning Regulatory Strategy, CMC Management, Medical Writing, Labeling and Artwork, along with Publishing and Submissions management. We have a proven track record of supporting over 200 clients and delivering 12,000-15,000 global submissions per annum.
One of the key advantages of working with Navitas Life Sciences is our extensive network of 250+ regulatory professionals who work with over 110 health authorities across the globe. This allows us to provide timely and accurate submissions for successful product launches and license management.
A region-specific project manager will be appointed to synchronize with client specifications and regulatory standards, ensuring a smooth and efficient project delivery process. Additionally, we have implemented a robust workload management tool to enhance project oversight and monitor deliverables effectively. This tool allows for real-time tracking of submission progress, accessible to both Navitas and the client's designated project manager.
RAPS Convergence 2023
Date: 03 – 05 October 2023
Venue: Montréal, QC, Canada
Navitas Life Sciences are pleased to be attending the RAPS Convergence 2023 event in Montréal, Canada.
Schedule a Meeting with our Experts at the Conference
Senior VP-Business Partner
Regulatory & Safety Technology
VP - Regulatory Services