The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on general-purpose computing platforms, such as smartphones or […]
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Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to
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Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure). As we navigate through 2025, staying informed about
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The pharmaceutical industry is undergoing a significant transformation, driven by the need for innovation and efficiency in pharmaceutical drug development. Drug development is a resource-intensive process that can take 10–15 years and cost billions of dollars to bring a medicine to market. One important aspect is the clinical trials, which face many challenges, including data
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Customer Requirement A pharmaceutical company required timely delivery of high-quality project management services without delays. The key objectives of the project were: Ensuring on-time and quality-driven execution of regulatory submissions Maintaining consistent project direction despite leadership changes Managing political and time pressures without compromising project timelines Ensuring timely submission of required documents from external stakeholders
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With its rapidly growing pharmaceutical industry and stringent regulatory requirements, South Korea is becoming a key global player. But for pharmaceutical companies, navigating this landscape requires strategic planning and compliance expertise. The Ministry of Food and Drug Safety in South Korea (MFDS), previously known as the Korean Food and Drug Administration, serves as South Korea’s
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The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing the cost of therapies. The complexities that even a slight manufacturing differences can lead to variations in protein structure, post-translational modifications, and glycosylation patterns. Since
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The global cosmetic industry is a complex and rapidly growing landscape where regulatory compliance is fundamental in ensuring product safety, efficacy, and market access. As cosmetic products cross borders, manufacturers must comply with country-specific regulations from ingredients safety to product labeling. These regulations protect consumers and set the standards that businesses must follow to enter
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Vaccines are an indispensable element of modern public health, playing an essential role in preventing infectious diseases and saving millions of lives annually. But at the core of any successful immunization campaign is an intricate multi-stage process known as Vaccine Lifecycle Management (VLM). This encompasses everything from early research and development (R&D) through post market
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Marketing Authorisation Holder (MAH) refers to a person or company that has been granted permission to market a pharmaceutical product within a specific country. MAHs are subject to a number of regulatory requirements and ensure pharmaceutical products meet stringent safety and quality standards. As regulatory frameworks are becoming more stringent, many companies are turning to
