Investigator_initiated Clinical Trials & Feasibility Assessment

Executing an IIT is often more complex for various reasons, including the necessity for industry support. Therefore, conducting an early feasibility assessment/evaluation before commencing an IIT can help address most challenges. Investigator-initiated trials (IITs) are typically conducted at academic hospitals and universities, distinguishing them from regular clinical trials in several aspects. What are Investigator-Initiated Trials […]

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Taiwan medical device regulatory and approval process

For entry into the Taiwan market, all medical devices require pre-market approval. The medical device market is growing in Taiwan, but getting into the nation requires strict adherence to regulations set forth by the Taiwan Food and Drug Administration (TFDA). Manufacturers must register their products with the Taiwan Food and Drug Administration (TFDA) to sell […]

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clinical trial logistics in africa and importer of records

In Africa, navigating logistics poses unique challenges, particularly in industries like clinical trials. However, Importer of Record (IOR) services offer a solution. By managing customs clearance and compliance, IOR services streamline clinical trial logistics, enabling organizations to focus on advancing medical research. Poorly developed logistics systems make it difficult to deliver necessary equipment and materials […]

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Software as a Medical Device

Regulatory oversight is crucial for ensuring the safety and efficacy of Software as a Medical Device (SaMD) solution. Understanding global regulations is essential for developers to navigate risk classification, quality management, post-market surveillance, and international standards, thereby ensuring compliance and fostering innovation in healthcare digitalization. SaMD presents a range of advantages that are reshaping the […]

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Clinical trial sourcing

Key strategies and best practices in clinical trial sourcing are crucial for ensuring the success and efficiency of research endeavors. Clinical trial sourcing encompasses the identification and acquisition of essential materials, services, and resources needed for the trial. This includes investigational products, laboratory services, trial sites, and patient recruitment strategies. Planning for clinical trial sourcing […]

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Oncology clinical trials in Asia-pacific region

The APAC region has had a remarkable increase in oncology clinical trial activity, and it is currently leading the world in the overall number of ongoing oncology clinical studies. The Asia-Pacific region has emerged as an epicenter of clinical trial activity, accounting for over half of total global clinical trials. With these growth tendencies projected […]

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Nutraceutical clinical trials in ASIA Pacific region

Nutraceutical clinical trials are steadily increasing in the Asia-Pacific region. The nutraceutical market in the Asia-Pacific is experiencing tremendous growth and is expected to expand further. The Asia-Pacific region, encompassing countries like Australia, India, Japan, and China, offers significant opportunities for the nutraceutical market due to its large population, rising disposable income, and growing focus […]

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Cosmetics registration process in Thailand

Cosmetic product registration in Thailand has become faster and more environmentally friendly since November 1, 2010, when the Thai FDA adopted a new online cosmetic product registration system. Thailand’s cosmetics business is expanding, offering a wide range of beauty and personal care products. Thailand established a comprehensive regulatory framework to ensure consumer safety while maintaining […]

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New drug registration process in south korea

As South Korea emerges as a focal point for new drugs, understanding the drug registration and approval process becomes crucial for those intending to market their products in the country. With a population that values advancements in healthcare, there’s a constant search for effective treatments and solutions in South Korea. The demand extends across numerous medical […]

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Asia Pacific Clinical Trials

The Asia-Pacific region, with over half of the global population, is becoming a growing popular spot for conducting clinical trials by offering lower trial costs, access to large patient pools, and a friendly regulatory environment. These distinguishing traits are increasing interest in medical device, pharmaceutical, and healthcare companies to shift their clinical trial locations to […]

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