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.
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…)
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…)
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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