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Total Product Life Cycle Advisory Program in Medical Devices

Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program

Blogs, Medical Device /

The medical device industry is driven by constant technological advancements and the need to meet growing patient demands. Ensuring that these innovations are safe, effective, and reach the market promptly is a critical aspect of public health. To address this need, the FDA has implemented the Total Product Life Cycle (TPLC) Advisory Program (TAP), a […]

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Gene Therapy Trials in EU

Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU

Blogs, Regulatory /

Gene therapy is recognized as a revolutionary approach in treating and potentially curing genetic disorders by correcting or replacing faulty genes. As the field progresses, navigating through the regulatory landscape for gene therapy trials in the European Union (EU) can be intricate due to a combination of clinical trial regulations and environmental legislation. Despite the

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EMA's expedited pathways

How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals

Insights, Regulatory /

At the DIA 2024 Global Annual Meeting in San Diego, key officials from the European Medicines Agency (EMA) shed light on the various expedited approval pathways available for sponsors of innovative drugs and Advanced Therapy Medicinal Products (ATMPs). This blog post explores the insights shared by EMA officials, delves into the various expedited pathways available,

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Managing Director of DDReg chosen as finalist for CPhI Pharma Awards 2024

News and Events /

DDReg is incredibly proud to announce that our Founder and Managing Director, Ms. Neeti Pant, has been chosen as a finalist by the prestigious CPhI panel for the “Woman of the Year” award at the CPhI Pharma Awards 2024, being held in Milan. This recognition is a testament to her visionary leadership, dedication to innovation,

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Japan’s Approach to eCTD V4.0

Blogs, Regulatory /

In the pursuit of global harmonization in pharmaceutical regulation, Japan which is renowned for its meticulous standards and innovative spirit, has taken a significant step by implementing the Electronic Common Technical Document (eCTD) v4.0. This move aligns Japan with international standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human

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Does the FDA need a new approval pathway?

Blogs, Regulatory /

The accelerated approval pathway is established to expedite the availability of drugs for serious or life-threatening conditions. It allows the FDA to approve treatments based on surrogate or intermediate endpoints before confirmatory studies are completed. This pathway has been instrumental in advancing treatments for rare diseases and unmet medical needs, relying on a balance between

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Regulatory Framework for Software and Artificial Intelligence as Medical Device

Blogs, Medical Device, Regulatory /

The convergence of healthcare with technology has led to giant innovations, one of the most significant being the use of software and artificial intelligence (AI) as medical devices. Such developments have been called Software as a Medical Device (SaMD) by many and have wide applicability in transforming the diagnosis, treatment, and care of patients medically.

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Specifications for In Vitro Diagnostic Devices

Blogs, Medical Device, Regulatory /

In vitro diagnostic medical devices (IVD devices) are an integral part of the healthcare system. They are typically used to analyze samples that are collected from the human body (i.e., saliva, blood, tissue, and urine) and help in diagnosing, screening, and monitoring various conditions. IVD devices are subjected to different regulations that specify different requirements

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Faster Access to Clinical Trial Information in Europe

Blogs, Clinical Regulatory /

Improving access to clinical trial information is critical in order to advance medical research while also ensuring patient safety. Enhanced transparency can not only accelerate innovation but also empower various stakeholders to make appropriate and informed decisions in order to progress medical research forward. The European Medicines Agency (EMA) has introduced several improvements in the

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