Sourcing or importing the IMPs and their supportive products is a challenging process for many researchers and this is more prominent with the countries like Japan and China where understanding the regulatory is difficult due to the language barriers and rapid changing norms for making imports.  Many key players in logistics are unclear about the […]

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As clinical trials have become increasingly global and complex, ancillaries have grown in volume, type, and expectations. The clinical trials supplies market is projected to reach  USD 2.5 billion by 2025 owing to the logistics services with the increasing number of clinical trials involving temperature-sensitive drugs. Currently, North America is the largest market for clinical […]

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Small and mid-size CROs occupy about 44% of the market share of outsourced development works, approximately. 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 Clinical Trials“, the top 10 CROs […]

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In recent years there is a huge leap in the pharma industry towards rare diseases and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Novartis, GSK, Roche, […]

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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 a tremendous surge […]

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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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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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Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]

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Do you know any product segment, where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While China has been the big production factory for generic drugs and API ingredients for many […]

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China has brought significant reforms in its regulatory system for pharmaceutical industry and clinical trials. In its continuous drive to improve the system, recently China‚Äôs Food and Drug Administration (CFDA) announced a major overhaul of its medical device regulations as well. To the current regulations, China has made significant changes. Summarily, 12 articles were newly […]

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