Category: Regulatory

0

Nutraceuticals & Food Supplements Registration Process In Thailand

The nutraceuticals and food supplements registration process in Thailand involves a comprehensive series of steps to ensure the safety, efficacy, and compliance of products entering the market. This process entails careful documentation, scientific substantiation of health claims, adherence to regulatory guidelines, and collaboration with regulatory experts. While timelines can vary, companies should anticipate a thorough […]

Read More →
0

Drug Registration & Approval Process In Singapore

The regulatory and approval of drugs in Singapore is a rigorous and comprehensive process. This is to ensure the safety, quality, and efficacy of drugs sold in the country. Although the process may be complex and time-consuming, people generally consider it transparent, predictable, and science-based. The significant market for therapeutic products in Singapore is expected […]

Read More →
0

The Importance Of Precise Translation In Regulatory Affairs

In the pharmaceutical industry, regulatory affairs and translation are critical. Regulatory affairs encompass the procedures and actions to ensure compliance with safety, efficacy, and quality standards set forth by relevant authorities for pharmaceutical products. Translation, on the other hand, refers to the accurate translation of regulatory documents, product labels, and instructions, from one language to […]

Read More →
0

The Importance Of Translation In Clinical Trials

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 →
0

Medical Device Registration Process With HSA In Singapore

For medical device companies looking to enter the Singapore market, the registration process can be complex and time-consuming. However, it is a necessary step 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 a number […]

Read More →
0

OTC Medicines Registration Process In Australia

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 →
0

How To Register A Prescription Medicine In Australia?

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 →
0

Marketing Authorization Holder (MAH) & Designated Marketing Authorization Holder (DMAH) For Product Registration In JAPAN

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 →
0

Medical Device Registration Process In Myanmar

Medical device registration is a mandatory requirement in Myanmar for companies seeking to market and distribute medical devices. The process involves submitting detailed documentation, including technical specifications, safety data, and evidence of compliance with local regulations. Myanmar offers tremendous business opportunities for U.S. exports of medical devices, equipment, and supplies. Myanmar’s private health sector depends […]

Read More →