by Global Regulatory Writing and Consulting | Jan 11, 2022 | General Interest
By: Sharon McFadden, DVM (Vice President, Clinical Operations & Medical Affairs) Figuring out a proposed budget for clinical sites can be challenging: knowing how to construct and execute the financials are a pivotal piece of trial design. Here are some...
by Global Regulatory Writing and Consulting | Jul 1, 2021 | Clinical Development
By: Linda Peterson (Vice President, Clinical Operations) and Sarah Schaul (Clinical Trials Manager, Clinical Operations) When choosing the best sites for a study, from the location of the sites to the country, there are many different factors that need to be...
by Global Regulatory Writing and Consulting | Jun 8, 2021 | Chemistry, Manufacturing, and Controls, Regulatory Technology
By Gangadhara Rao Vakkalagadda Artificial intelligence (AI) is the next big thing coming, and it is already starting to shape our world. People worldwide are embracing this technology in the form of smartwatches, smartphones, smart home systems, and self-driving...
by Global Regulatory Writing and Consulting | May 25, 2021 | COVID-19, General Interest, SARS-CoV2
By Rebecca Lynch With the arrival of the new coronavirus, SARS-CoV-2, research is growing in the area of rapid, safe limitation of airborne and surface viral transmissions. One usage is a type of ultraviolet (UV) light device for disinfecting surfaces and objects,...
by Global Regulatory Writing and Consulting | May 11, 2021 | Chemistry, Manufacturing, and Controls
By Gangadhara Rao Vakkalagadda The U.S Food and Drug Administration (FDA) has worked with industry to streamline the Abbreviated New Drug Application (ANDA) approval process since the early 2010s. The administrative powers to do so began with the enactment of the...
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