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, CE 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. CE 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.

[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER

Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.