Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA.
You’re developing a drug, biologic, or medical device product. There are a lot of moving parts involved in obtaining regulatory approval from the European Medicines Agency (EMA) and local national agencies. This can sometimes involve working with and managing a number of different vendors, which can be extremely cumbersome with redundant communication flows and many points of contact.
Learn how our experienced regulatory consultants provided one client with full regulatory-related product lifecycle management support across all 31 countries within the European Economic Area (EEA), offering a single point of contact which created a more efficient and expeditious regulatory process.
Related Resources
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...
Navigating the Generic Drug Application and Approval Process
Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...