by Prakash Achaary | Jan 31, 2019 | Blog
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
by Prakash Achaary | Jan 17, 2019 | Blog
When a clinical trial is completed, regardless of the outcome, the results need to be shared. From a regulatory perspective, they have to be shared. On the other hand, from the perspective of disseminating information throughout the scientific community, researchers...
by Prakash Achaary | Jan 3, 2019 | Blog
In the early 2000s, I sat in an undergraduate microbiology lab and caught the bug. It was not a laboratory-acquired infection, but inspiration from a world only seen under the microscope. The order and the vast unknown was intriguing, leading me to expand my...
by Prakash Achaary | Nov 29, 2018 | Blog
Medical writers are the people that tell the story of new drugs coming to market. It’s a very important job, and one that needs to be performed to exact specifications. While attending the invitation-only Medical Writing Executives Forum: Preparing for the Future of...
by Prakash Achaary | Nov 8, 2018 | Blog
Plain language summaries, commonly known as lay summaries, have become increasingly important for pharmaceutical companies in recent years. However, there are many sponsors that have yet to start their pilot programs for these documents. To answer some commonly-asked...
