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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Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Kelley Hill

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU up!”, a good physical trainer listens to your goals and then develops a plan to help you achieve them. Likewise, experienced regulatory and medical writers possess the unique blend of talent— scientific acumen, oral and writing communication skills, project management expertise, and deep knowledge of the regulatory landscape— that can help you develop a strategic roadmap for your drug.

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Topics: Regulatory Writing
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