This is the third in a four-part blog series that examines the Clinical, Medical Affairs, Regulatory, and Safety product domains at ArisGlobal.
ArisGlobal Marketing met with Pratyusha Pallavi, Senior Director, Regulatory Product Head at ArisGlobal. The Regulatory Domain of ArisGlobal is leading the way in conceiving and building Industry Standard Practices enabled software for transforming regulatory affairs departments of Life Science companies around the globe. The conversation included such topics as her role in regulatory solutions and department vision.
What helped prepare you for your role at ArisGlobal both before you started working here and now that you have been with the company for some time?
Before working for ArisGlobal, I have designed Electronic Health Records software used by US and Asia-Pacific hospitals for managing processes and data for their patients along with administered drug products and medical devices. My experience with electronic health records helps me understand the perspective of the patient. Why it is important to track information about a drug product, what kind of information to track, and so on. Now at ArisGlobal, on the life sciences side, I understand why it’s important to reduce time to market for the product and get the right specifications approved. The regulatory department is kind of the gateway between the life sciences organization, the health authorities, and the market.
After joining ArisGlobal more than a decade ago, I have contributed to product strategy, process design, and customer success of our regulatory customers. I have been able to leverage my experience in innovation business case, customer voice elicitation, product road mapping, go-to-market strategy, and product evangelizing for B2B enterprise cloud-based products.
I consider myself bi-lingual, as I speak both technical and business language. This allows me to convert market insights and customer needs into future-facing software. This ability has been seasoned by crafting lofty goals in an entrepreneurial environment combined with being grounded by values and a structured execution approach of a global conglomerate.
Another item that has helped me in my role at ArisGlobal is the relationships I have built with top leaders in pharma. With these, I can seek out and leverage their expertise to deliver on the Industry Standard Practices (ISP) vision of ArisGlobal.
What type of clients utilize LifeSphere Regulatory solutions?
Our customers are Regulatory Affairs departments of life sciences companies. LifeSphere Regulatory solutions cover all product types including Pharmaceuticals, Biotechnology, Medical Devices, Biologics, Cosmetics, and Veterinary. We service innovators as well and generics for products that are either currently in clinical trials or those that are already in the market. We work with R&D companies, manufacturers, and Contract Research Organizations (CROs). Even health authorities need regulatory software.
What is the vision for your department?
The vision for the regulatory department of ArisGlobal is to ensure that we provide an automation based, unified platform that enables the regulatory affairs departments of all life science companies to succeed in their transformation projects and their undertakings. Many regulatory departments are now realizing that their old, historic, and disparate systems, which are not connected, will not work anymore. ArisGlobal would like to focus on ensuring that we provide a comprehensive, unified product for pharmaceutical companies, medical devices companies, and other such segments. We are especially focusing on making our platform automation enabled, intuitive and truly unified for supporting end-to-end capabilities across all functions and teams in the regulatory department of all types of life sciences companies.
How easy is it for an organization to implement the use of ArisGlobal’s LifeSphere Regulatory?
Our Industry Standard Practices driven software products have preconfigured out-of-the-box configuration that allows regulatory affairs to kick-start their business process. The configuration is by country, by product type, by submission type, and other such regulatory dimensions. This means that our solutions have the regulatory intelligence built-in so that end-users don’t have to start from scratch. Additionally, we are heavily focusing on a structured methodology to automate regulatory use cases by leveraging a wide variety of Artificial Intelligence capabilities. That is what LifeSphere ® Nava is all about, which will enable faster adoption of regulatory best practices, leading to higher productivity and associated cost savings, end-user engagement, and adoption by global regulatory organizations in pursuit of their 2025 transformation goals.
To learn more about LifeSphere® Regulatory and how integrating compliance with the business process over the entire product management lifecycle, read our whitepaper “Regulatory 2025: Developing an Effective 10-Year strategy for Technology-Enabled Regulatory Transformation”.
To learn more about LifeSphere® Nava, our groundbreaking cognitive computing engine that delivers real-world automation to the drug development lifecycle, read our whitepaper “Cognitive Computer in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System”.