On May 14, 2020, ArisGlobal hosted a webinar titled Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies, hosted by Pratyusha Pallavi, Senior Director of Regulatory and Quality at ArisGlobal.
In this webinar, Pratyusha discussed how Regulatory Affairs in small and medium-sized pharmaceutical organizations (SMP) have a unique set of challenges and needs as compared to their larger brethren. As they prepare for accelerated growth, their regulatory tools need to grow alongside them and at the same pace. In the past, smaller companies could rely on spreadsheet tools or other rudimentary systems to manage documents, dossiers, and submissions. With accelerated growth comes the need for more robust and comprehensive solutions.
As companies grow, they often expand into additional countries and territories. This expansion causes them to become faced with rapidly evolving and diverging regulations in addition to a steadily growing workload of regulatory submissions. Due to the small company size and often limited resources, including monetary and personnel, there may be a lack of funding or time to invest in a replacement system as it could entail a lengthy software implementation cycle.
Regulatory agencies of these small to medium-sized businesses need expertise and guidance to provide cost-effective solutions to handle their growing needs in a quick and cost-efficient manner. Investing in software to manage regulatory requirements is much more than just an IT investment. It’s a research and development investment as well, with a focus on digital maturity.
This webinar examines the five main factors to consider when addressing digital maturity:
- Scalable Journey towards Maturity – Rapid business growth demands accelerated regulatory affairs digital maturity, but in controlled stages
- Responsiveness – Growing workload of regulatory submissions during rapidly evolving and diverging regulations
- Expertise and speed – Limited resources are not available for solution design and lengthy implementation cycles
- Simplicity and Ease of Adoption – Pressure to quickly demonstrate productivity gains on IT investment
- Controlled Budget for IT – R&D and not IT is the primary investment
To learn more about the LifeSphere Regulatory platform, you can view this webinar on-demand – Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies
To find out how our regulatory affairs products can help your team, read our whitepaper – Regulatory 2025: Developing an Effective 10-year Strategy for Technology-Enabled Regulatory Transformation