Clients engage WAYS because of our expertise. Over 50 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 85 submissions per month
Submitted 10 original applications within 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.)
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.