Freyr Solutions

  Blinded studies   are the cornerstone of clinical trial integrity, eliminating bias and ensuring objective evaluation of investigational products. However, behind the scientific rigor lies a critical creative component—the package labels for clinical trials. For Regulatory artwork teams, designing for blinded trials is a balancing act between compliance, confidentiality,  and clarity . At  Freyr Solutions , we specialize in regulatory-compliant, audit-ready artwork for global clinical trials. In this blog, we explore how clinical trial packaging artwork must be tailored to meet the  unique demands of blinded studies . Why Artwork Matters in Blinded Studies Designing packaging labels for  blinded studies  (typically in clinical trials) involves unique processes to  maintain blinding and ensure compliance  with Regulatory and trial-specific requirements. Unlike commercial products, the artwork for blinded studies must  conceal product id...

  In the highly regulated and documentation-heavy world of life sciences, regulatory publishing and submissions have traditionally been a complex, manual, and time-consuming process. As global health authorities tighten submission standards and timelines shrink, life sciences companies are turning to Artificial Intelligence (AI) and automation to revolutionize the way they manage regulatory content.  In this blog, we explore how technology and AI are transforming regulatory publishing—from document formatting to validation to QC, and finally submission—and what it means for the future of regulatory operations.  What Is Regulatory Publishing?  Before diving into AI’s role, let’s clarify what regulatory publishing entails. Regulatory publishing involves:  Formatting clinical and nonclinical documents in ICH-compliant formats (e.g., eCTD)  Ensuring document navigation (bookmarks, hyperlinks)  Validating submission packages against regional specifications ...

  In today’s fast-evolving healthcare landscape, patient safety is more than just a regulatory requirement—it is a strategic imperative. As life sciences companies navigate complex therapeutic areas, accelerated drug development cycles, and global regulatory pressures, risk management systems (RMS) are evolving into intelligent, proactive tools that safeguard patients across the product lifecycle.  This blog explores the latest innovations in risk management approaches, with a focus on how life sciences companies can prioritize patient safety while staying compliant, efficient, and future-ready.  Why Risk Management Is Critical to Patient Safety  From clinical trials to post-marketing surveillance, risk management is the backbone of pharmacovigilance and regulatory compliance. Traditional methods—like static risk management plans (RMPs) and reactive safety measures—are no longer sufficient to address:  Rising complexity in biologics and combination products...

  A Regulatory Writer’s Guide to LBS In today’s fast-paced life sciences arena, literature-based submissions (LBS) have emerged as an agile, cost-effective, and scientifically robust route to Regulatory approval. If your organization is looking to optimize resources without compromising scientific rigor, this blog is for you. What is an LBS—and When Is It Appropriate? A  literature-based submission (LBS)  relies primarily—or entirely—on published, peer‑reviewed data, rather than sponsoring proprietary clinical or non‑clinical studies. Regulatory authorities typically allow LBS in scenarios where: The active ingredient has a well-established registration history in mature markets (>10 years), with consistent use across countries like the US, UK, Canada, EU, and New Zealand. You’re pursuing label expansions, dosage updates, pharmacokinetic/pharmacodynamic changes, or new indications . There’s limited—or no—company‑sponsored data to support certain submission modules, par...

  In the competitive world of healthcare, publishing a clinical study is no longer the final destination—it’s just the beginning. The challenge today?   Ensuring that your evidence reaches the right stakeholders, in the correct format, at the right time. That’s where  publication extenders  come in. These powerful tools transform dense scientific data into accessible, digestible, and engaging formats that resonate with a diverse audience, from busy physicians and payers to patients and policymakers. What Are Publication Extenders? Publication extenders are alternative formats that expand published studies' reach, utility, and lifespan. Instead of letting valuable data sit in journals, life sciences companies are turning findings into: Plain Language Summaries (PLS)  – Simplified versions for patients and the public. Infographics  – Visual snapshots of key clinical outcomes. Video Abstracts & Animations  – Animated overviews of study goals and findi...

  The South Korea pharmaceutical market is one of Asia’s most dynamic and rapidly evolving pharmaceutical landscapes. Backed by strong healthcare infrastructure, government investment in R&D, and robust regulatory oversight, offering significant opportunities for global pharmaceutical manufacturers. However, entering this market requires navigating a highly structured and detailed regulatory framework governed by the   Ministry of Food and Drug Safety (MFDS) . This blog serves as a comprehensive guide for pharmaceutical manufacturers aiming to establish a compliant and competitive presence in South Korea. 1. Regulatory Authority Overview  in the South Korea Pharmaceutical Market At the core of South Korea’s pharmaceutical market oversight is the MFDS (Ministry of Food and Drug Safety). Formerly known as the Korea Food and Drug Administration (KFDA), MFDS is responsible for regulating drugs, medical devices, cosmetics, and food. It ensures that pharmaceutical products ...