FDA Modernization Act 2.0: Accelerate Readiness with an Advanced LIMS Solution
In April 2025, clinical research reached a turning point, with advances reshaping both the science and the regulations that guide it. The FDA unveiled its Roadmap to Reducing Animal Testing in Preclinical Safety Studies, offering a phased strategy for integrating non-animal methods into drug development. Around the same time, the NIH announced the launch of […]
Structured Content Authoring (SCA) in Clinical and Regulatory Documents
In our previous post, we explored how AI is transforming regulatory and clinical documents, moving from hype to real, measurable value. In this second installment, we take a closer look at Structured Content Authoring (SCA), a foundational capability that enables reuse, traceability, and automation at scale. SCA is more than a technical upgrade. It is […]
Advancing Quality Control Testing in Therapeutic Biologics
Quality control (QC) testing is paramount in ensuring the efficacy and safety of therapeutic biologics. These complex molecules, derived from living organisms, require stringent testing to meet regulatory standards and ensure patient safety. While state-of-the-art molecular methods have been established, many laboratories still rely heavily on animal testing, using protocols developed in the 1970s. However, […]
Understanding Compliance Regulations in the Life Science Sector Part 1
Compliance with industry regulations is non-negotiable in the fast-paced and highly regulated realm of life sciences. Navigating the intricate web of rules and standards is essential to ensure product and service safety, efficacy, and quality. This blog seeks to unravel the complexities of compliance regulations in the life science sector, providing a comprehensive understanding for […]
How to Effectively Use Your Federal NIH Grant Award
When you are awarded a federal NIH grant, it’s essential to know how to use the grant award effectively. The post-award phase may seem overwhelming with various implementation and reporting requirements, but adhering to the grant terms and conditions is necessary. This blog post will guide you toward maximizing the use of your grant award […]
What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug […]
Global Pharmaceutical Company Develops Regulatory Labeling Quality Support Strategy
Overview Pharmaceutical labeling is a highly regulated, complex process that must be operating efficiently to guarantee quality and safety. However, businesses frequently struggle with compliance difficulties, particularly when they are involved in international marketing. This is a major concern for the corporation and a problem with the regulatory bodies. The major impact to the organization […]
Astrix Webinar – Insights to Succeed Throughout the Regulatory Information Management RIM Journey
Astrix On Demand Webinar for Regulatory Information Management – Insights to Succeed Throughout the Regulatory Information Management RIM Journey
White Paper – Insights to Succeed Throughout the Regulatory Information Management (RIM) Journey
Download the new White Paper There are many benefits of implementing an end-to-end Regulatory Information Management (RIM) system including the impact on regulatory compliance, speed to market, and revenue. A robust RIM solution can optimize collaboration and streamline processes driving higher quality work, faster. However, to reap these benefits, organizations need to ensure they have […]
World Drug Safety Congress Conference Wrap Up
Astrix had the opportunity on Oct 4-5 to participate as a Gold Sponsor of the World Drug Safety Congress conference in Boston, MA. This event had over 1000+ pharmacovigilance and safety experts in attendance. The list included pharma and biotech companies, along with academic, government, regulators, and vendors who came together to discuss the key […]
What the FDA Guidance on Data Integrity Means for Your Lab
Regulatory agencies worldwide are increasingly focusing their efforts on data integrity in GxP laboratories. This increased focus has led to a number of guidance documents being published on data integrity in 2016, including: The World Health Organization (WHO) published its final version of “Good Data and Records Management Practices” guidance document The European Medicines Agency […]
FDA’s Guidance on Genetic Testing: What You Need to Know
In traditional medical care, diseases are typically detected via chemical changes associated with a particular condition and all patients receive a similar dose of a medication as treatment. While this one-size-fits-all approach has led to great advancements in medicine, it has by no means been successful for all patients. Over the last decade, a new […]