Criterion Edge FAQs

The Intersection of Skill and Scalability in Regulatory Writing Services

Here are answers to some common questions we receive. Need to know more? We’d love to hear from you.

Tell me more about how Criterion Edge writers stay current with global regulatory guidelines?

Glad to! Criterion Edge invests in and supports the regulatory expertise of its writers. Through the use of internal and external regulatory training programs and SOPs, CEI ensures its writers are kept up-to-date with US and oUS regulations and guidelines. We do the training for you and can provide documentation of the experience of the medical writers we assign to your projects.

What are the qualifications and experience of Criterion Edge writers and project managers?

All project managers and medical writers hold advanced scientific degrees such as Masters, PhD, MD, and PharmD. CEI team members are matched to the therapeutic area and type of document needed for each project, aligning their particular expertise and skill set to the requirements of each project.

For more detailed information on our experience and capabilities, click here.

What if I don’t see the report or service that I need listed on the website?

Just ask us! Our talented writers have wide-ranging experience with many medical writing projects across multiple therapeutic areas. In addition to regulatory medical writing, we can provide publication support, abstracts, posters, white papers, advisory board support and slide sets. We’ll match the best writer to the particular needs of your project.

Laurie Mitchell

CE President, Laurie Mitchell, discusses safety reviews

Sign up for this free webinar today!

Title: Intro to Adverse Event Review
Date: Wednesday, July 18, 2018
Time: 11 am PST | 2 PM EST
Details: 30 minute presentation | 30 minute Q&A