Regulatory Writing Services

Writing is a people skill.

Technology gives us the ability to quickly analyze vast amounts of information; rapidly design new drug or device therapies; innovate as never before. But with all the power that technology delivers, it takes scientific expertise to analyze data, make conclusions and produce an accurate, clearly written document.

Experienced in all phases of drug, biologic and medical device product development, the CE project managers and regulatory writers work together with our dedicated support team to provide our clients state-of-the art regulatory writing service. We know that every project’s demands are unique. Whether you need a writer dedicated to a single project, or a larger team with project management support, CE has the resources and bandwidth to rapidly scale up to meet project timelines. If you are seeking a collaborative partner to augment your medical device, pharmaceutical/biologics, or other internal regulatory writing initiatives, contact Criterion Edge.

How does Criterion Edge augment and support my internal team?

Flexibility is the answer. Depending on the needs of the project, CE can contract with clients to provide:

  • One or more dedicated writers for short-term or long-term projects, or...
  • A client-facing project manager leading a CE writing team. This solution harnesses the full scalability of the CE solution to ramp up or down depending on the demands of the project. Our project manager acts as your single point of contact and manages the CE team to meet your timelines and deliverables.

Click to see a listing of our expertise: Documents and Services

[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.