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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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Accelerating access to Women’s Health products

Case Studies, Regulatory /

Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they

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High Impact Manager Program

DDReg & Oktane HR – “High Impact Manager Program”

News and Events /

DDReg places a strong emphasis on continuously nurturing and expanding its leadership team to drive long-term organizational success. In line with this vision, DDReg was fortunate to have been supported by Oktane HR- a leadership and growth focussed consultancy that is dedicated to refining leadership capabilities and learning. Principal consultant, Mr. Sunil Bhardwaj, and Lead

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Web-based Lifecycle Management Tool

Case Studies, Regulatory /

Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the

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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 Application Pathway

Understanding the FDA’s Abbreviated New Animal Drug Application Pathway

Insights, Regulatory /

The level of scrutiny surrounding animal medicinal products has strengthened more adverse events (AEs) associated with such products have emerged in animals. Indeed, AEs and adverse drug reactions (ADRs) is a cause of concern for veterinarians. Several cases of toxicity from commonly used drugs have been reported, in canines, for example. These include licosamides that

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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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Regulatory Excellence

DDReg features in BioPharma Dive

News and Events /

End to end global regulatory services driven through technology-enabled solutions.DDReg featured in BioPharma Dive, a leading Pharmaceutical Industry publication that provides insight into emerging trends and news that are driving the Industry. Among these trends is outsourcing regulatory affairs that have brought substantial value to the business by saving cost & resources, de-risking other business

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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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