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US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials

Blogs, Pharmacovigilance, Regulatory /

Decentralized clinical trials (DCTs) are evolving and gaining momentum within medical research as they increasingly incorporate state-of-the-art digital health technologies (DHTs). Indeed by way of DHTs, useful data for clinical trials can be collected, exchanged, transferred, and stored electronically and in a more efficient manner. In order to stay aligned with the momentum, regulatory agencies […]

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Innovative Medicines

Evaluating PRIME: A Pathway for Innovative Medicines

Blogs, Regulatory /

In various therapeutic areas where life expectancy is low, delayed market access to effective medicines has highlighted the need for expedited responses by regulators to support timely access to such priority medicines. The Priority Medicines Scheme, or PRIME, was implemented by the European Medicines Agency (EMA) to support and accelerate medicine development that targets unmet

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Clinical Practice

Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape

Blogs, Pharmacovigilance, Regulatory /

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline update- the ICH E6 (R3)- that focuses on the application of Good Clinical Practice (GCP) to new trial designs, technological advancements, and enhancing a risk-based approach in clinical trials.The ICH E6 (R3) serves as an update to

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FDA Compliance

How do Artwork Management Systems help maintain FDA compliance?

Artwork Management Services, Blogs, Regulatory /

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

Blogs, Medical Device, Regulatory /

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

Blogs, Regulatory /

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

Blogs, Medical Device, Regulatory /

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

Blogs, Pharmacovigilance, Regulatory /

Introduction 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 monitoring a clinical trial to help make sure that the rights, safety, and welfare of trial participants are protected. For this, sponsors are required to implement a system that manages

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Digital Future of Healthcare

Digital Future of Healthcare

Blogs, Medical Device, Regulatory /

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

Blogs, Medical Device, Regulatory /

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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