Ensuring timely and accurate Regulatory submissions can be a daunting task. The volume of processes, systems, and supporting tools needed to plan, track, author, publish, and submit to Health Authorities can be staggering. The process can be more complex when global affiliates require Rest of World (ROW) submissions.
Pharmaceutical companies with which we’ve worked can find it a heavy lift to complete and streamline the seemingly myriad of tasks. We’ve seen efforts encounter challenges, due to a lack of consideration and coordination among multiple, related organizations.
In this podcast RIM expert, Heather Adinolfi discusses the strategies and tactics that can effectively:
· Identify and anticipate common hurdles,
· Mitigate the impact of common unavoidable challenges, and
· Smooth the road to success with Regulatory Information Management.