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 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...
by Global Regulatory Writing and Consulting | Apr 12, 2021 | Chemistry, Manufacturing, and Controls, Generics
By Rebecca Lynch April 13th, 2021 This year Global is excited to target a new growth area in generic drug submissions (ANDAs, or Abbreviated New Drug Applications). We’ve built a strong foundation in CMC and small molecule submissions, and we think our expertise in...
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