Generic drug market and regulatory in Asia_pacific region

Navigating the Asia-Pacific generic drug market involves grappling with regulatory requirements and overcoming diverse challenges. Stakeholders navigate a dynamic landscape, from strict safety standards to complex supply chains and pricing pressures, demanding adaptability and strategic maneuvering for success. Generic drugs surge globally for their cost-effectiveness, bioequivalence to brand-name counterparts, and adherence to stringent safety, efficacy, […]

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Why choose India for conducting clinical trials in India

India is becoming a popular choice for clinical trials due to several key advantages and benefits. The country offers a promising environment with a diverse patient population, making it ideal for gathering comprehensive data. With a population exceeding 1.3 billion, including a substantial patient pool across various demographics and medical conditions, India offers a vast […]

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The Asia-Pacific Generic Drug Landscape: Key Insights

The Asia-Pacific region, with its growing population, growing healthcare needs, and attempts to cut costs, is one of the major players in the generic drug market. In recent years, the Asia-Pacific region has seen a significant push towards using generic medications to cut costs and improve efficiency in healthcare systems. This trend is evident across […]

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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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