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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December 12, 2017

3 Approaches to Increase Flexibility and Scalability in Your Regulatory Writing

Frustrated Businesswoman

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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May 12, 2017

How Outsourced Regulatory Writing Can Benefit Your Organization

Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?

In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. (more…)

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May 12, 2017

New MEDDEV Guidelines: What You Need to Know

In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance? (more…)

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Generis American Medical Device Summit

October 24-25, 2018

The Westin Lombard Yorktown Center
Lombard, IL 60148

 

Schedule a meeting with our President, Laurie and our CEO, Lalitha

Haven’t registered yet? Contact us to get your 65% discount code!