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FDA Compliance

How do Artwork Management Systems help maintain FDA compliance?

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The pharmaceutical industry is a highly regulated environment where investing in a reliable and efficient method for managing artwork can result in significant cost savings. Artwork management forms an integral part of regulatory affairs. The main objective of an artwork management system is to ultimately prevent product recall. Pharmaceutical companies invest significant time, money, and […]

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Drug Device Products

Drug-Device Products: Navigating through the EU

All Category, Blogs, Medical Device /

Drug-device combination (DDC) products are increasingly demonstrating the value they bring in diagnosing, treating, and curing complex diseases. The growth of the DDC market is driven by several factors including an increase in chronic diseases, a well-established medical technology industry, a rise in surgical procedures, the availability of funding for research and innovation etc. As

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Digital Health Technology

Indian Perspective on Digital Health Technology

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Digital health technology has gained significant momentum in India, revolutionizing healthcare delivery and improving accessibility and efficiency. It acts as a fundamental support for providing value-based care throughout the healthcare system. Various digital health technologies, including telemedicine and health monitoring apps, are transforming the healthcare landscape in India.The Indian Prime Minister introduced the National Digital

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Digital Health Technology

Challenges With Medical Devices and Digital Health Technologies

All Category, Blogs, Medical Device /

Currently, there are over 2 million diverse types of medical devices accessible in the global market, which are further classified into more than 7000 generic device groups. As of 2021, the worldwide medical devices market was valued at USD 488.98 billion and is predicted to grow at a compound annual growth rate (CAGR) of 5.5%

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Monitoring Clinical Trials

Risk-Based Approach to Monitoring Clinical Trials

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Introduction -: Risk Based Monitoring Clinical Trials Clinical trial sponsors for pharmaceutical products (drugs and/or biologics for human use, medical devices, combination products, etc) are required to provide the oversight for risk based monitoring a clinical trial to help make sure that the rights, safety, and welfare of trial participants are protected. For this, sponsors

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Digital Future of Healthcare

Digital Future of Healthcare

All Category, Blogs, Medical Device /

Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve

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Artificial Intelligence

Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device

All Category, Blogs, Medical Device /

Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and

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Pharmaceutical

WHO Pre-qualification pathway: advancing access to vaccines

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Introduction Malaria is one of the biggest and most pressing tropical and infectious diseases that pose a significant  threat to public health- particularly children. In 2019, a study analysis found that malaria caused 643,000 deaths globally with children <5 years of age living in Africa and exhibiting the highest disease burden [1]. According to the

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Pharmacovigilance

DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions

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The European Medicines Agency (EMA) has created a sustainable network called DARWIN EU, which aims to generate real-world evidence to support regulatory decision-making in the European Union. This coordination centre network uses data analysis techniques and real-world interrogation methods to extract information and insights from various data sources, including structured and unstructured sources. Its main

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Remote Inspections

Real-Time Remote Inspections – The New Normal

All Category, Blogs, Pharmacovigilance /

IntroductionThe onset of the pandemic was one of the most hard-hitting events that impacted millions of people around the globe. On one hand it brought along life-changing repercussions and challenges that were first of many, but it also triggered industries to adopt innovative solutions in their everyday practices. One of these many solutions was instigating

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