What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products.

When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively

When preparing regulatory submissions, especially in fields like oncology, it's crucial to focus on the end goal—the drug's label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market.

Writing is often thought of as a solitary task. An author sits in a quiet, isolated environment, plugging away with their thoughts. With regulatory writing, this couldn’t be further from the truth. Instead, it’s often a chaotic mix of emailing colleagues, coordinating timelines, and managing input from stakeholders.

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization.

Last year I had the pleasure of participating in the Synterex Regulatory Writing and Medical Communications Fellowship. I worked with and learned from Synterex staff members across all areas of the business, including medical writing, project management, quality control (QC), publishing, and business operations.

We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it got wrong.

Business skills matter. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.

Difficult people exist in any profession. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. Sooner or later, you’ll have to work with someone whose personality clashes with yours. T

Checklists are a great tool. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. We have a complicated job. Every day there are new tasks to manage, learn, and get right.

If you work for a team that tackles complex tasks, you are likely familiar with the benefits of having a project manager. Project managers ensure that the team achieves its goals within the given budget and time constraints. But do you know what a regulatory project manager is, and how their specialized expertise can help?</p>

<p>Each year, Synterex is proud to welcome students and postgrads to a medical writing internship or fellowship. Our current intern, Alex, and our current fellow, Katelyn, answer some questions about the experience so far. What is your educational background? Alex: I am a rising senior at Clark University, currently studying for a major in Biology&hellip;</p>

<p>FDA’s public meeting on February 24th left no uncertainty as to the future direction of drug development in rare disease: Patient-centric approaches that incorporate patient and caregiver input at all levels to ensure that clinical trial endpoints are robust and meaningful; and Utilization of patient data (registries, cases, natural history, and real world evidence) </p>

<p>When you look at job descriptions for medical writers, have you noticed that, regardless of the size of the hiring company, you end up with an array of interpretations of the role? Here are some examples: Medical writers may or may not write briefing books, write or review labels, or assist in regulatory responses </p>