Services

Our consultants have extensive experience in SDLC and CSV including 21 CFR Part 11 compliance.  We can manage your project from the ground up

in your regulated environment using your internal SDLC/CSV methodology or bring our own to bear.  We can even help to develop a methodology that fits your organization.  Just ask!

Our ERES services range from helping you find tools and services that are right-sized to make your submissions successful to hands-on submission preparation.  We can also gap your current process to help you improve it.  This is one of our strongest and most in-demand service areas.

Business analysis is at the heart of most of our services.  We work to make sure that your new system or enhancement project goes smoothly from start to finish by getting the requirements documented and, most importantly, accurate.  We can provide process diagrams, use cases, user stories, and any other business artifact to ensure success.