BREXIT, the withdrawal of the United Kingdom (UK) from the European Union (EU) and the European Atomic Energy Community (EAEC or Euratom), has changed the way business is done in a wide variety of industries. Since the pharmaceutical industry is the third largest industry across the UK, the fact that life sciences professionals will be affected makes perfect sense. As industry leaders think of ways to stay ahead of regulatory changes caused by BREXIT, the Covid-19 pandemic is making the path to clarity even more difficult. Thankfully, with an easy-to-use cloud application like ArisGlobal’s LifeSphere RIMS, there are ways regulatory professionals can mitigate the changes caused by BREXIT.
How BREXIT Affects the Regulatory Landscape
Major aspects of regulatory affected by BREXIT are marketing authorizations, XEVMPD submissions and legal presence requirements. This aspect of pharma is necessary by law to place medicinal products on the market. LifeSphere RIMS accelerates speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application. It provides seamless access to regulatory documents and full support for all major eCTD submission requirements. This makes it easier for regulatory teams to stay on top of vital market authorizations. Additionally, with its built-in automation feature, teams can reduce the administrative workload and have ultimate confidence in the quality of data they provide when registering products.
How LifeSphere RIMS Can Help
LifeSphere RIMS is the perfect solution for teams to reduce risks and stay compliant with the latest regulatory requirements. Its scalable cloud architecture simplifies things through continuous innovation and free, easy upgrades. RIMS is a cloud application that has been designed with a complete understanding of the regulatory life cycle. So naturally, it allows the industry’s best configuration with full support for xEVMPD and IDMP data standards.
In the coming months, the impact from BREXIT will continue to affect pharma and the regulatory sector in different ways. With its out of the box features around converting procedure types and registrations that will be used to handle the impact of BREXIT on UK product registration data sets, LifeSphere RIMS is an excellent way for regulatory teams to move quickly, streamline collaboration and deliver quality in one application.