Japan is a key market for the pharmaceutical industry, but its drug approval process can be complex and daunting. If you are seeking to introduce a new drug into the Japanese market, you must understand the drug approval process and navigate it effectively.
- November 10, 2023 Pharmaceuticals, Regulatory Affairs
- November 8, 2023 Cosmetics Regulatory Services
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a historic milestone in the US FDA's oversight of cosmetics. It represents the most significant expansion of the US FDA since the inception of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938.
- November 8, 2023 Pharmaceuticals, Regulatory Artwork Services
In the pharmaceutical industry, precision, safety, and compliance are paramount, and hence the role of artwork quality checks holds a critical place. It's not just about aesthetics; it's about ensuring that every piece of artwork adheres to strict Regulatory standards and maintains the integrity of the brand.
- November 8, 2023 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry operates in a complex landscape where compliance with stringent regulations is paramount. One area where this is particularly crucial is in the creation and management of Regulatory artwork. Regulatory artwork encompasses everything from packaging and labeling to product inserts and documentation.
Unlocking the Potential of South Korea's Pharmaceutical Industry: An Overview of the NDA/BLA Process
November 8, 2023 PharmaceuticalsPharmaceutical businesses looking for new business prospects find South Korea to be an attractive market with a fast-increasing pharmaceutical industry. With over nine-hundred (900) new drugs in the pipeline and exports totalling USD 3.1 billion, South Korea provides enormous potential for big pharma manufacturing.
- November 7, 2023 Medical Devices
The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.
- November 6, 2023 Food and Food Supplements
Japan’s food and dietary supplement market holds great appeal, drawing health-conscious consumers who search for high-quality products. However, you need to navigate a strict Regulatory environment to enter this thriving market.
- November 6, 2023 Food and Food Supplements
When it comes to labeling requirements for food and dietary supplements in the European Union (EU), you must pay close attention to detail. The EU has established strict regulations to ensure that consumers receive accurate and transparent information on the products they consume.
- November 2, 2023 Medical and Scientific Communication, Pharmaceuticals
In the highly regulated and dynamic pharmaceutical industry, medicinal product-related promotions and advertisements aim to increase brand awareness, generate sales, or create brand loyalty. A high amount of pharmaceutical budget (nearly 9.3 million U.S. dollars in 2022 as per Statistics (Marketing budgets of U.S. healthcare companies 2019-2022; Published by J. G.
- November 2, 2023 Pharmaceuticals, Compliance, Audit and Validation
In recent years, Regulatory bodies have adapted to new technologies and compliance demands by implementing remote inspections. This shift, accelerated by the COVID-19 pandemic, has allowed these agencies to continue monitoring compliance while minimizing physical interactions.