Synterex Blog

Using Speculative Fiction Techniques to Enhance Regulatory Submissions   Speculative fiction is a broad genre of literature that explores...

In the realm of communication, whether it is a casual conversation, a persuasive speech, or a clinical study report, our words carry more...

When you align your writing with both your strengths and the world’s needs, you create more than just content - you create impact.  In...

Discover how AI and structured content management are transforming regulatory submissions—boosting speed, consistency, and compliance in health authority interactions.

The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, re

Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them. 

Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...

Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.

When implemented thoughtfully, AI can enhance job satisfaction, improve digital employee experience (DEx), and foster a great workplace culture.

Cancer unfolds when mitosis, or the process of cell reproduction, decides to break all the rules and go rogue. Despite significant strides in scientific understanding and cancer treatment, including use of artificial intelligence (AI) to accelerate cancer immunotherapy research, recent updates from the American Cancer Society cast a shadow on our optimistic journey.

AgileWriter™ is an AI tool designed specifically for medical writing, developed by experts in the field to meet the precise needs of clinical documentation. Importance of Subject Matter Experts: Involving subject matter experts (SMEs) in the creation of AI tools for medical writing ensures the tool is practical and meets user needs, avoiding misalignment and inefficiencies.

Pediatric drug development is one of the most challenging areas of regulatory writing, where precision, guidance interpretation, and strategic planning are crucial to achieving regulatory success. Medical writers play a pivotal role in ensuring that regulatory submissions are clear, compliant, and robust enough to meet the unique needs of pediatric populations.

As we age, the complexity of our health often increases, leading to the management of multiple chronic conditions. This reality gives rise to a phenomenon known as polypharmacy, or the simultaneous use of multiple medications in a single patient. Polypharmacy is a significant concern.

According to the National Diabetes Statistics Report, 5.7% of all United States (US) adults with type 1 diabetes rely on insulin for managing their condition. Additionally, approximately 12.3% of US adults started using insulin within a year of their diabetes diagnosis.

In the ever-evolving battle against infectious diseases, the rise of drug-resistant infections poses a significant challenge to global health. These resilient bugs have developed mechanisms to withstand conventional treatments, leaving scientists and healthcare professionals searching for innovative solutions.

In the realm of pharmaceutical innovation, the Investigational New Drug (IND) application is a pivotal gateway, marking the initiation of clinical trials and the potential journey toward a groundbreaking new medication.

Chronic Kidney Disease of Unknown Etiology (CKDu) has emerged as a pressing public health concern, particularly in regions with high agricultural activity and limited access to healthcare.

Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any submission activities, ensure you have secured the FDA's agreement on both the timing and the scope of your rolling submission.

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.

<p>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 1.&hellip;</p>