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Author Archives: Jennifer Moen

Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

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Most Common Advice We Give First Time NDA/BLA Submission Teams

June 14, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing & Corporate Communications | Medical Writing Services

Throughout the years, our staff at IMPACT has worked with many clients on marketing applications (large and small) across a variety of therapeutic areas. Each one comes with its own unique challenges, but the most interesting (and often the most exciting) are those where the client is working on a submission for the first time.

Such client teams can represent a small company bringing their first drug to market, or a first-time team within large pharma. Though their corporate atmospheres may differ, the challenges they face on their first submission can be similar.

Without further ado, here are the most common 5 pieces of advice we give to first time submission teams. [Reader’s Note: In this post I use the term “submission” to mean a marketing application (eg, NDA, BLA, MAA).]

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In Case You Missed It: Four Themes from the DIA 2016 Annual Meeting

July 7, 2016 | Jennifer Moen, PhD, RAC, Principal Clinical Research Scientist | Medical Writing Services, Regulatory Affairs, Drug Development Consulting

Did you miss the DIA 2016 Annual Meeting? If so, no worries! This post presents 4 themes that were evident throughout the conference. Please remember that these are based on my own personal DIA experience – other attendees may have come away with different messages.

Here we go…

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7 Tips on How to Write for a Regulatory Reviewer

June 8, 2016 | Jennifer Moen, PhD, RAC, Principal Clinical Research Scientist | Medical Writing Services

Ever tried to write a document and you weren’t sure where to start? The answer is – put yourself in the shoes of your audience and work from that mindset. In our industry, the audience is typically from a regulatory agency (eg, FDA, EMA, PMDA) – and could be a clinical, statistical, or CMC reviewer, among others.

Here are 7 tips on how to write effective documents for review by a regulatory audience.

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