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.
For more information on our capabilities, click to see a listing of our expertise: Documents and Services.

Contact us for a free consult today.

[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.

Spots are limited – click to register for this free webinar.

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Named the #1 Regulatory Services Company 2022 by Life Sciences Review