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New Revolution with Multimedia and eConsent

Revolutionizing Informed Consent: Are Multimedia and eConsent the New Norm? 

All Category, Blogs, Clinical Regulatory, regulatory /

Informed consent is a critical part of ethical clinical research, designed to ensure participants fully understand the nature, risks, and benefits of a trial before enrolling. However, for years, traditional paper-based consent processes have fallen short. Dense language, static formatting, and lack of personalization have made it difficult for many participants to grasp what they […]

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Complete Guide to the Egypt Medical Device Registration Process

How to Register a Medical Device in Egypt: Regulatory Pathways with the EDA 

All Category, Blogs, regulatory /

Egypt is fast emerging as a strategic healthcare hub in the MENA region, with a growing market for medical devices. For manufacturers looking to access this market, understanding the regulatory framework laid down by the Egyptian Drug Authority (EDA) is critical. Unlike the traditional pharmaceutical landscape, medical device registration in Egypt is governed by its

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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

FDA Clinical Hold Lifted with DDReg’s Toxicology Expertise Read More »

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

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

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

Types of Vigilance Every Life Sciences Professional Should Know  Read More »

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

Placebos in Clinical Trials: A Fundamental Component of Medical Science  Read More »

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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