The current COVID-19 situation is having a profound impact on life science industries, including the pharmaceutical industry and companies manufacturing medical devices. As unprecedented pressure is placed on healthcare systems and hospital and medical needs continue to change, companies need to stay agile and able to adjust their priorities on demand.
Many industry leaders are looking to expedited regulatory pathways and Emergency Use Authorizations (EUAs) to get essential equipment and products to front-line workers quickly. Meanwhile, the medical device industry is facing pressure as a result of shortages, even as many experts find themselves with more questions than ever about compliance. These questions have become even more complex due to how quickly the pandemic situation is evolving.
At Regulatory Compliance Associates, we understand you’re doing all you can to serve medical professionals and the wider community. We honor that effort by helping you extend support to public safety and front-line workers during the COVID-19 pandemic.
Remote Regulatory Affairs Consulting for Maintaining Compliance
Since 2000, Regulatory Compliance Associates has been working directly with clients, giving us extensive experience in helping organizations resolve quality and regulatory challenges to stay fully compliant with FDA regulations. In the current climate, we recognize there may be even more questions about FDA compliance with EUAs and regulatory pathways which may be shifting temporarily to accommodate today’s unique needs.
While we are known for our direct and on-site service, Regulatory Compliance Associates is currently working to offer most services through virtual meetings to keep your team and our team safe. If you require on-site reviews during this time, we have an extensive network and resources across the country to serve you. In these cases, we will work quickly to coordinate on-site systems and resources to continue to meet your needs.
We have reviewed our remote policies and processes in light of the current situation to ensure our communication remains consistent and secure.
Regulatory Compliance Associates Is Here for You
Now more than ever, leaders in the life science industries are turning to Regulatory Compliance Associates. We are vigilant in staying up-to-date on changing regulations so you can meet FDA obligations even as your business is rolling out devices or products at an unprecedented rate. As always, we are continually mining regulatory intelligence to keep up with new changes.
If you have concerns about regulation in light of the current situation, you can always turn to us for compliance support — our remote services ensure you continue to get specialized services while keeping your team safer.
At Regulatory Compliance Associates, we have always prioritized communication and knowledge. Today, we recognize that those values are more important now than ever before. We look forward to standing by you and continuing to offer the exemplary service you depend on. If you have questions about compliance or FDA-related issues during the pandemic, rest assured we remain here to help. To learn more about our services or our COVID-19 response, please reach out to us online.