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Case Study on FDA Clinical Hold for toxicological

FDA Clinical Hold Lifted with DDReg’s Toxicology Expertise

All Category, Case Studies, Clinical Regulatory, Regulatory /

Customer Requirement A US-based biopharmaceutical company conducting early-phase clinical development encountered a regulatory hurdle when the US FDA placed a clinical hold on its Phase 2 study application for a higher dose. The hold was issued due to toxicological findings observed during preclinical studies. To move forward, the company required scientific rationale and justification to […]

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AI-Powered Regulatory Submissions in 2025

AI-Powered Regulatory Submissions: A New Era for IND, NDA, & BLA Documentation 

All Category, Blogs, regulatory /

Regulatory submissions have always been the linchpin of drug development. From paper-based dossiers to the globally adopted electronic Common Technical Document (eCTD), the journey of regulatory documentation has continuously evolved. However, as life sciences companies contend with increasing data volumes, complex global regulatory requirements, and pressure to accelerate time-to-market, even eCTD processes are showing their

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Types of vigilance in life science industry

Types of Vigilance Every Life Sciences Professional Should Know 

All Category, Blogs, Pharmacovigilance, regulatory /

In the global life sciences industry, whether you’re launching a new pharmaceutical, a medical device, or a personal care product, the responsibility doesn’t end at regulatory approval. It extends across the product lifecycle, driven by a commitment to patient and consumer safety, and reinforced by an evolving web of global regulatory requirements.    Traditionally associated

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Insights on the FDA's Project Pragmatica for Clinical trials and life science industry

FDA’s Project Pragmatica and the Rise of Embedded Pragmatic Trials

All Category, Clinical Regulatory, Insights, Regulatory /

 The traditional randomized controlled trial (RCT) has long been the gold standard for evaluating the efficacy and safety of medical interventions. However, its inherent rigidity, limited generalizability, and operational burden have raised questions about its efficiency in today’s rapidly evolving healthcare landscape. In response, the U.S. Food and Drug Administration (FDA) launched FDA’s Project Pragmatica,

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Role of Placebos in Clinical Trials for Medical Science

Placebos in Clinical Trials: A Fundamental Component of Medical Science 

All Category, Blogs, Clinical Regulatory /

Suppose you are taking a pill, fully aware or sometimes not aware that it contains no active ingredients and yet experiencing an improvement in your symptoms. While this may sound implausible, it illustrates the remarkable reality of the placebo effect an enduring phenomenon that has both puzzled and guided the medical community for centuries. In

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Current Trends in Advanced Therapies 2025

All Category, Blogs, regulatory /

Breakthroughs in biotechnology are transforming how we approach some of the most challenging medical conditions. Genetic disorders, late-stage cancers, and severe tissue damage are increasingly being treated with therapies tailored to each individual’s unique biology. From gene therapies that rewrite faulty DNA to cell-based treatments that regenerate damaged tissue, advanced therapies are not just reshaping

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Training Support on Process Validation Methods case study

Technical Upskilling through Expert Training Support on Validation Methods

All Category, Case Studies, Regulatory /

Customer Requirement A leading India-based pharmaceutical manufacturer with global operations sought to strengthen its internal technical capabilities related to Analytical Method Validation (AMV) and Process Validation (PV). With increasing regulatory scrutiny from agencies such as the FDA, EMA, and ICH, the company aimed to ensure compliance with current global guidelines while fostering cross-functional understanding across

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From Waste to Worth: Aligning Your Packaging Strategy with the EU PPWR

All Category, Blogs, regulatory /

Imagine a world where every pill bottle, blister pack, and shipping box not only protects life-saving medications but also safeguards our planet. The PPWR, officially designated as Regulation (EU) 2024/1781, replaces the previous Packaging and Packaging Waste Directive 94/62/EC with a more harmonized approach to packaging sustainability. The EU PPWR Regulation officially entered into force on

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Regulatory oversight of companion apps

Regulatory Oversight of Companion Apps: Where Do They Stand? 

All Category, Blogs, Medical Device, regulatory /

Imagine sipping your morning coffee while an app effortlessly syncs with your glucose monitor. These are companion apps, digital tools that extend the functionality of medical devices. But with innovation comes responsibility. So, who ensures these apps are safe, effective, and secure?  Companion apps, particularly in healthcare, are rising fast. But the regulatory frameworks that

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