One of the most sought-after markets for medical devices globally is the Australian market. With the regulatory reforms and increasing demand for innovative products, the Australian medical device market expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing the medical device approval […]

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Small and Mid-Sized Contract Research Organizations (CROs) for clinical trials occupy approximately about 44% of the market share of outsourced development works. These CROs are gaining interest and becoming the choice for startups, small and mid-sized pharmaceutical and biological companies. While in the first part of this article series on “Contract Research Organizations For Your […]

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The United States remains the largest medical device market in the world with $156 billion which is 40 percent of the global medical device market in 2017 and By 2023, it is expected to grow to $208 billion The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines […]

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Do you have scientific evidence that the country chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources to conduct clinical trials? Have you compared it with other eligible regions? To find answers to all these questions, you need to perform proper clinical trial feasibility. […]

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The global contract research organization market value reached $39 billion in 2018 and is expected to exceed $51 billion by 2024. The market is becoming competitive, with large CROs going for acquisitions and mergers to increase the portfolio and reach, whereas small and medium CROs are becoming more prominent with their personalized approach, contact flexibility, […]

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This article is a sequence of the Regulatory & Drug Approval Process in the United States, Part-I, which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways.  Which is the regulatory authority […]

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The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]

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Clinical research professionals and staff members say that one of their biggest challenges in conducting a clinical trial is patient recruitment which is obtaining a sufficient number of participants for a clinical trial. If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study […]

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