Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with tremendous surge of […]

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Rare diseases are rapidly becoming a high priority therapeutic area for our industry. This is needed, especially when fewer than 5% of approx 7,000 rare diseases have drug therapies available, and many of these provide limited benefit. There is also a business case to this, due to a supportive reimbursement environment, particularly in the US. […]

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Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also gaining traction in rare diseases drug development.  Developing medicines or drug products in rare diseases is always challenging for both the scientific and clinical development team […]

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Nutraceuticals or Health supplements are gaining importance and becoming a part of the consumer’s daily diet. With the increase in life expectancy and subsequent increase in lifestyle-related diseases, nutraceutical or health supplements have emerged as a necessity for consumers, especially in a developed market and Europe is not an exception to it! Novel food represents […]

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Credevo Global Network for Clinical Development and Product Registrations

Cost and time for clinical development constitute more than 70% of total development of any drug! Small – mid scale biopharma are known for their innovative approaches, agility and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent comprised of clinical segment, the global CRO market was estimated at $31.6 billion in 2018 and is expected to grow at a CAGR of 12 percent to reach $45.2 billion by 2022 according to a report. Contract research organizations (CRO)’s are the companies […]

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Over a few years, the rate of drug development in rare diseases is increasing, particularly in those countries where the regulators are offering various incentives for drug development in rare diseases. Over the past five years, one-third of the approved drugs were to treat rare diseases. The huge leap of pharma industry into the rare […]

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Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally? Numerous complementary medicines are recognised as a premium brand in Australia and internationally. The obvious reason being – Australia’s complementary medicines industry is proudly backed by a regulatory regime that is regarded as one of the strictest in the world! […]

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Nutraceutical, dietary or food supplement products, also known as “Health Supplements” have been in use since many years to maintain, enhance and improve the healthy function of human body. These may contains one or more, or a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances. Each country differs in […]

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Australian regulators do not distinguish between medicines and complementary medicines when it comes to safety, efficacy and quality of the product, including the imported products! Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia. To […]

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