The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]

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Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, regulatory support, etc. Applying a perfect strategy for clinical development in rare diseases may help overcome these challenges and accelerate the drug development process […]

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Drug development is a lengthy, complex, and costly process entrenched with a high uncertainty that a drug will successfully reach the market. So for this, you need a proper drug development strategy to avoid uncertainties and complete clinical trials in time with quality data. Drug development is a process to bring a new pharmaceutical drug […]

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Drug development is the process of bringing a new pharmaceutical drug to the market after identifying a lead compound through drug discovery. The drug development process starts from drug discovery and ends gaining market approval and post-marketing studies, This entire process of medical device/drug development takes years and depends on many factors such as Type […]

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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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Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]

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Regulatory agencies of various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work upon developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]

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Do you know? Global regulators consider Australian Nutraceuticals complementary medicines () the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines’ approval follows a strict regulatory regime and is one of the stringent in the world!. With such high quality of these products, the Australian complementary […]

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Concerning the safety, efficacy, and quality of the product, Australian regulators review and register nutraceuticals, same as pharmaceutical products, concerning the safety, efficacy, and quality of the product. To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process. Read the first part of […]

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