The GLOBAL Perspective: Regulatory Consulting & Beyond
Exploring the intersection of Life Science innovations, insights, and current industry topics within regulatory consulting.
Responsible AI in Medical & Regulatory Writing: Why Expert Oversight Matters
Generative AI tools are starting to revolutionize how many industries engage with regulatory obligations. We discuss the opportunities and challenges in working with AI, and outline how our team of medical writers can support your project to ensure quality submissions.
The Use of Neutral, Unbiased, and Equitable Language in Medical Writing
It is increasingly important in medical writing to recognize diversity in race and ethnicity, sex and gender, sexual orientation, socioeconomic status, and disability, and to avoid assumptions about a patient’s identity or medical condition.
Overcoming the Challenges of Complaint Reporting with IMDRF Adverse Event Terminology
The IMDRF framework offers a solution to challenges associated with complaint reporting by providing a standardized set of terminologies for adverse event reporting, streamlining processes, and improving the accuracy of reported data.
M. Jocelyn Elders: Breaking Barriers as a Trailblazing Pediatrician and Public Health Administrator
M. Joycelyn Elders rose to prominence as an influential pediatrician and public health advocate, and she served as the first black woman appointed Surgeon General of the United States. Learn more as part of our Women in Science Series.
How Do You Know When You’re Ready to Submit an IND? Part 1
Read about the core requirements for a successful IND submission, the strategic advantages of scheduling a pre-IND meeting, and how to prepare in a way that not only streamlines the review process but also reduces the risk of encountering a clinical hold.
Gertrude Elion: A Pioneer in Cancer Research and the Development of Life-Saving Medications
Gertrude Elion was a trailblazer in scientific innovation through her lifelong commitment to medical research and the treatment of cancer and disease. Learn more about her as part of our Women in Science Series!
