Medical Writing
Syner-G’s Medical Writing Fellowship Program: Preparing Professionals for a Career in Regulatory Medical Writing
February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical Writing Services Regulatory medical writers play a key role in facilitating the development and compilation of documents that are…
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Advice for First Time NDA/BLA Submission Teams
Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, ANDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found…
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Regulatory Medical Writing: Who is your audience?
Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing…
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Keep ’em Coming: An Overview of IND Updates
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of…
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From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes,…
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Current Topics in Orphan Drug Development
December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND…