Regulatory & Medical Writing

Agreeing to Submission Document Timelines and Sticking to Them: Fairy Tale or Reality?

Steve Sibley

Does the thought of developing a submission for the marketing approval of a new drug fill you with dread? How do you avoid losing all of your holidays and weekends when developing a submission? Or burning out your team? In my career, I’ve helped teams develop robust submissions with minimal disruption to people’s lives and […]

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Topics: Regulatory & Medical Writing

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Diving into Best Practices for Pooling Clinical Trial Data

Steve Sibley

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated […]

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Topics: PK/PD Modeling & Simulation, Regulatory & Medical Writing

Is Your Approach to Regulatory Writing the Elephant in the Room?

Steve Sibley

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this: A group of blind men hear that an elephant has arrived in their village. Being blind, […]

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Topics: Regulatory & Medical Writing
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