Accelerating Regulatory Submissions

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Collaborate and Innovate to Speed Up Your Timelines

“How can we go faster?” Sound familiar? While aggressive deadlines seem daunting, teams that partner closely with executives will accelerate decision-making. 

Regulatory teams are in a unique position to merge strategic goals with operational realities. In this piece, IPM’s regulatory experts explore why to embrace the “go faster” mandate and how to work better with management and relevant functions. Together, you can beat the competition to market, retain investor confidence, and get life-enhancing therapies to the patients who need them. 

Download “Working Together to Accelerate Regulatory Submissions” to learn:  

  • The benefits of partnering with executives, such as becoming known as a strategic decision-maker. 
  • Considerations for accelerating regulatory submission timelines without sacrificing quality. 
  • How to weigh the risks and benefits of various acceleration methods to inform prioritization, resourcing, and budget decisions. 
  • Specific ways different regulatory roles can work faster, as well as real-world examples of how they did so. 

Susan Carino

 

Susan Carino is a Principal Consultant with more than 25 years of experience in R&D across numerous therapeutic areas. She specializes in global regulatory strategy development and regulatory project management for submissions. She leads diverse cross-functional program teams engaged in complex product development of new pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests.

 

 

Rani Maloney

 

Rani Maloney is a Senior Consultant with more than 20 years of experience in the life science industry. With a background in clinical quality, her recent focus has been providing program and project management consulting services for cross-functional, global teams engaged in late-stage clinical development programs and regulatory submissions.  

 

Related Links

Services: Regulatory Submissions
Industries: Life Sciences