OUR EXPERIENCE

Clients engage WAYS because of our expertise. Over 50 sponsors continue to choose WAYS as a trusted partner because we apply our expertise in innovative ways. We focus on building credibility and mutual trust as we deliver compliant output, 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 submissions.

  • Organized, compiled, published and submitted thousands of submissions over the past 15 years

  • Submitted an average of 85 submissions per month

  • Submitted 10 original applications annually

  • Experience with submissions across all therapeutic areas

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

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

Members of our team bring an average of 15 years of experience in Regulatory Operations to their roles.