REGULATORY SUBMISSION SERVICES
The WAYS team partners with our clients to offer long and short-term solutions. Our services afford flexibility and scalability to growing teams while delivering critical capabilities. We become seamlessly integrated into your process and, ultimately, help to achieve your submission goals in the most efficient manner.
Delivering Regulatory Excellence
Our experienced team knows how to accurately interpret guidances and regulations, develop successful strategies and implement efficient processes. Our best practices are formed by our extensive submission expertise.
Members of our team bring an average 15 years of experience in Regulatory Operations to their roles and each has submitted over 150 INDs, 30 marketing applications (US, EU, CA), and 5000 lifecycle submissions.
Customized training programs that introduce eCTD concepts including document granularity and submission lifecycle management.
The WAYS team offers valuable guidance in developing and implementing the most effective and efficient eCTD submission strategies.