REDEFINING SUBMISSION MANAGEMENT

WE ARE YOUR SOLUTION

Collaboration
 

The WAYS Team works closely with clients to help you reach your goals. We are with you every step of the way. Our submission expertise is only rivaled by our responsiveness. We have developed and maintained strong partnerships with our clients who trust us with their valuable R&D assets.  

Innovation
 

The WAYS Team thrives on innovation. Our team’s expertise enables us to get the most from industry standard tools to ensure quality and compliant submission deliverables. We have developed and implemented best practices and are constantly improving upon them.

 

Commitment

The WAYS Team is committed to your success. It's just that simple. When you achieve your goals, we achieve ours. We are committed to delivering quality work and an exceptional client experience. No drama and no trauma - just solid expertise delivered where and when you need it.   

 

Podcast Banner.jpeg

Congratulations to Allison Steffen!

2020 Regulatory Excellence Award for Support

 

OUR CUSTOMER'S VOICE

“We originally chose WAYS as our Submission Management Partner because of their expertise and efficiency. Sarepta continues to work with them because of their responsiveness and flexibility. They understand our business and are committed to helping us reach our goals, usually under tight timelines. Ways is a great partner and we’re glad to have them on our team!”

Gary Charbonneau
SVP, GM Gene Therapy COE
SAREPTA Therapeutics

The Submission
Management Challenge

Being great at submission management requires a unique combination of skill sets and expertise that are in high demand. It requires an understanding of relevant electronic submission guidances and standards but also the ability to discern and interpret guidances in practical submission settings.

It demands a command of relevant technologies but one must also have the proficiency to apply appropriate tools to the compilation and organization of documents, data and metadata in a meaningful way.

This level of practical knowledge represents an ongoing investment. Many small and growing organizations don’t have the budget to develop these internal capabilities. Others are concerned about the risk of missing a deadline or not understanding a compliance rule that may result in a technical rejection of a submission and delays in the review process.  

The Regulatory Submission is the final step in a long and expensive R&D process. The quality of the submission must reflect the effort and the science within it. That’s why so many sponsors choose to partner with us. We take the drama and trauma out of regulatory submissions. Our clients choose WAYS to get the job done.