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Why ELSA Is a Step—but Not the Destination—for AI in Regulatory Writing
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

Jeanette Towles
5 days ago


Evaluating Your Medical Writing Department Menu of Services in the Age of AI
Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.

Jeanette Towles
Mar 18


Staff Retention: The Hidden KPI for Adoption of AI-Enabled Medical Writing
When implemented thoughtfully, AI can enhance job satisfaction, improve digital employee experience (DEx), and foster a great workplace culture.

Jeanette Towles
Mar 18
The Unfolding Cancer Crisis: Breaking the Rules of Mitosis and Rising Incidence
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.
Diksha Diundi
Jan 10
Why Subject Matter Experts Are Essential in Creating AI-Enabled Medical Writing Tools
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.

Jeanette Towles
Dec 6, 2024
The Critical Role of Medical Writers in Pediatric Drug Development
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.

Jeanette Towles
Nov 14, 2024
Navigating Medication Jenga: The Challenge of Polypharmacy in Geriatric Patients
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.
Alex Olinger
Nov 11, 2024


Insulin: The Savior of Millions
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.
Diksha Diundi
Nov 8, 2024
Bug Busters: Creative Combat Against Drug-Resistant Infections
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.
Alex Olinger
Nov 5, 2024
Navigating the Frontier: An Introduction to Investigational New Drug (IND)
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.
Alex Olinger
Oct 9, 2024
Harvest of Sorrow: The CKDu Crisis
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.
Alex Olinger
Oct 3, 2024
Key Considerations for Submitting Your NDA or BLA to FDA on a Rolling Basis
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.
Alex Olinger
Sep 6, 2024
Biosimilar Laughs: A Chuckle in Every Dose
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.
Alex Olinger
Aug 28, 2024
10 Most Common Risks to Your BLA or NDA Timeline (and How to Mitigate Them)
<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.…</p>

Jeanette Towles
Aug 25, 2024
Writing Regulatory Submissions with the Label in Mind: Key Strategies for Success
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.
Alex Olinger
Aug 19, 2024
Regulatory project management: keeping things on track
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.
Alex Olinger
Apr 12, 2024


Your Document’s Path to a Successful Quality Control Review
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.
Alex Olinger
Oct 24, 2023
ICH E6 (R3): Implications of Recent Updates for Medical Writers
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.
Alex Olinger
Jun 8, 2023
My Fellowship in Medical Writing: What I Learned
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.

Katelyn Rivas
May 19, 2023


Hey ChatGPT? Tell Me a Story
We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it got wrong.
Alex Olinger
Jan 14, 2023
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