Explore how the EMA’s 2025 Real-World Evidence Framework is reshaping regulatory submissions—and what it means for medical writers navigating structured data and evolving reviewer expectations.

Learn how Synterex helps biotechs turn regulatory uncertainty into advantage through expert strategy, automation, and AI-enabled efficiency.

Albert Einstein once said: “If you can’t explain it simply, you don’t understand it well enough.” Einstein’s words echo a principle at...

When I read McKinsey’s article, Rewiring Pharma’s Regulatory Submissions with AI and Zero-Based Design , I  couldn’t help but feel a mix...

As artificial intelligence becomes an increasingly powerful tool in regulatory and clinical writing, many professionals are eager to...

You’re diligently working away on a regulatory document that’s due tomorrow morning, when you get an email from the study team that they...

In your role as medical writer, you’ve just been assigned to write a regulatory document. To do your best, you’ll need to...

In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents.

In today’s fast-evolving digital landscape, digital employee experience (DEx) is more than just a buzzword—it’s an essential aspect of organizational success, particularly for professionals like medical writers.

As clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline processes, and improve regulatory compliance. While the benefits of e-consent are significant, implementing this technology also presents several challenges that sponsors and clinical teams must navigate.

Lean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without unnecessary detail. It promises efficiency, but the reality of implementing lean authoring within a cross-functional team often involves substantial negotiation. Lean authoring becomes not a black-or-white process but, rather, an exercise in grayscale methodology.

For a drug to get on the market in the United States, it must go through a rigorous review by the FDA's Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]).

Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product's approval process. To succeed, it's important to follow best practices that focus on clarity, accuracy, and efficient project management.

As Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, most of us don’t understand anything but English. Since we typically have far fewer vacation days than other countries, our vacations tend to be short.

In the realm of medical writing, titles like "regulatory" or "pharma" may take center stage, overshadowing the less emphasized term "ethical medical writer."

We’ve all seen a lot of articles in the last few years about the pros and cons of the remote work environment.

Many side effects can result from poor posture: shoulder, neck and back pain, circulation issues, dizziness and even depression, to name a few. 

Pronoun conversations are popping up all over; and, luckily, they’re spreading to the workplace, too. As pronouns are deeply personal, it’s important that this part of a person’s identity is both respected and accepted at work. 

Medical writers are experts at writing detailed scientific documents geared toward scientists, clinicians, and regulatory agencies. However, sometimes we are asked to prepare documents for a lay audience. These can include lay summaries of clinical study reports, informed consent forms, or other patient education materials.

National Entrepreneurship Day is a celebration of innovation, determination, and the pursuit of the American dream. It's a day to honor the entrepreneurs who have dared to dream big, take risks, and build businesses that not only benefit themselves but also contribute to the growth of our economy.