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OUR EXPERIENCE

Clients engage WAYS because of our expertise. Over 60 sponsors continue to choose WAYS as a trusted Regulatory Submission Management Partner (RSMP) because we apply our expertise in innovative ways.

 

We focus on building credibility and mutual trust as we deliver compliant submissions, expert advice, and an exceptional customer experience.

 

The WAYS team has:

  • Experience submitting to FDA CDER, CBER and CDRH, Health Canada, and European health authorities in support of Centralised, Decentralised, and National procedure

  • Experience with submissions across all therapeutic areas

  • Submitted an average of 230 submissions per month 

  • Submitted 40 original applications within the past year

  • Submitted over 2,800 lifecycle submissions in the past year

  • Never received a Refuse-to-File (RTF) based on technical reasons

  • Practical knowledge of industry-standard tools for document management, publishing, submission compilation, and viewing

  • An understanding of the nuances of eCTD submissions and the impact of underlying technologies (XML, PDF, etc.)​

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Collaborating on a submission

Our Experience is Your Advantage

We work with a wide variety of clients in various stages of the submission lifecycle. Almost 40% of our current clients transitioned from other vendors.

 

We apply our practical experience to simplify the transition process so our clients can be up and running in as little as a few days.

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