Feb 10, 2021 | News, Regulatory
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the... 
Jan 7, 2021 | Clinical Trials, Health, Language Service Provider, Medical Translation, Pharmaceuticals, Regulatory
With a population of more than 1.3 billion people, India is one of the fastest growing economies in the world. As their global economy continues to expand, and as clinical trials are continuing to be conducted overseas, India remains unique in both the opportunities... 
Jul 10, 2020 | Medical Writing, Regulatory
We’re here this week with Dr. Nimita Limaye, a distinguished leader in the international medical writing community and a recent addition to CSOFT Health Sciences’ growing team in Boston, Massachusetts, in the role of Senior Vice President, Strategic Partnerships &...Jun 8, 2017 | Clinical Trials
Several years ago, clinical trials in India were a booming business. After becoming fully compliant with TRIPS in 2005, India was seen as a favorable place to conduct clinical trials as they boast a huge genetically diverse population, as well as a multitude of...
