May 3, 2018

Benefits of Outsourced Medical Writing

As business increases, medical device and pharmaceutical companies are finding success turning to outside vendors to meet their technical and regulatory writing needs. In doing so, these organizations gain real and specific benefits that, because of a streamlined approach, can lead to a bigger bottom line. Below are a few examples of the advantages that your company can gain by outsourcing your writing needs.

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January 11, 2018

[Infographic] Medical Writing Budget Control: 5 Key Questions to Help Manage Your Budget

Regulatory writing and publishing is a critical component in regulatory affairs, and manufacturers must comply with varying regional regulations and increasingly rigorous disclosure and evaluation standards. Companies therefore need good strategies to keep the budget for medical writing in check, while meeting escalating demands, evolving regulations, and unrelenting timelines.

Are you are asking yourself, “How can I get the most out of my project budget?” We can help you answer this. (more…)

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December 12, 2017

3 Approaches to Increase Flexibility and Scalability in Your Regulatory Writing

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What is trying your patience these days? Changing guidelines? Higher standards for methodological rigor? More frequent submissions? The bar for regulatory writing keeps rising with no end in sight. Add training requirements, unforeseen developments, and conflicting deadlines, and you will likely find your writing team struggling to keep up. (more…)

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October 30, 2017

10 Implications to Medical Device Companies caused by the MedDev v4 Requirements

Medical device industry standards are in constant flux. Standards are frequently updated to meet conformity requirements. So what are the clinical requirements that you need to be aware of to stay compliant? (more…)

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October 12, 2017

Medical Device Single Audit Program: The Basics

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Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the MDSAP and why is it important? (more…)

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