Regulatory affairs and translation play a crucial role in the pharmaceutical industry. Regulatory affairs refer to the processes and activities involved in ensuring that pharmaceutical products comply with the regulatory requirements of the relevant authorities. These requirements include safety, efficacy, and quality standards. Translation, on the other hand, refers to the accurate and timely translation […]
Read More →Translation plays a crucial role in facilitating accurate communication between participants, researchers, and sponsors in conducting clinical trials on a global scale. This can be a challenging task, especially when language barriers come into play. Clinical trials are critical for developing new drugs, medical devices, and treatments. These trials aim to test the safety, efficacy, […]
Read More →For medical device companies looking to enter the Singapore market, the registration process can be complex and time-consuming, but it is a necessary step in order to ensure compliance with regulatory requirements and bring products to market. The medical device industry in Singapore has seen significant growth in recent years. The market is driven by […]
Read More →The process of registering over-the-counter (OTC) medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). The exact process depends on the type of product and the regulatory pathway, but typically involves the submission of detailed documentation and scientific data to support the safety, quality and efficacy of the product. What are OTC (over-the-counter) […]
Read More →We use Standard Operating Procedures (SOPs) – uniformly written instructions with thorough explanations – to document common tasks, procedures, and organizational practices. SOPs in clinical research define the group’s standard practices and daily research procedures to ensure that we carry out research tasks in compliance with institutional, state, and federal guidelines. We should create SOPs […]
Read More →The registration of prescription medicine in Australia is straightforward, and the TGA evaluates applications for quality, safety, and efficacy. Australia ranks among the largest healthcare markets worldwide as its health system is one of the best in the world and provides quality, safe and affordable healthcare for its citizens. The value of the Australian pharmaceutical […]
Read More →Medical device regulations vary from country to country, and this is not different in Japan. To register your medical device in Japan, you need to look for these top 6 considerations to make your registration process easy. Japan is a global economic powerhouse with one of the largest medical device markets. In terms of US […]
Read More →If you plan to register a healthcare product in Japan, previously you would need an In-country caretaker system. After the revision of the Pharmaceuticals and Medical Device (PMC) Act, the Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH).replaces the In-country caretaker system The foreign manufacturer who plans to register their products in Japan […]
Read More →Myanmar offers tremendous business opportunities for U.S. exports of medical device, equipment and supplies. Myanmar’s private health sector depends on imported medical equipment and supplies to meet the increasing local demand for high-quality health services. In Myanmar, there are no specific laws governing medical & IVD devices,and laboratory diagnostic testing in Myanmar. Such matters generally […]
Read More →Myanmar depends on imports for nutraceutical supplements and over-the-counter products. The nutraceutical supplements market in Myanmar is very competitive. Pharmaceutical spending is growing at double-digit growth, and researchers expect it to reach USD 1.1 billion valuations by 2023. Considering the huge opportunities in Mynamar, many companies are showing interest in registering and marketing their products […]
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