Navigating the Regulatory landscape of chemicals in Japan can be a complex and challenging, especially for businesses seeking to import or manufacture chemicals within the country.
- February 7, 2024 Chemicals, Regulatory Affairs
- February 7, 2024 Chemicals, Regulatory Affairs
Chemical registration is a vital process that ensures the safe handling, usage, and distribution of chemicals within a country. In Thailand, the Food and Drug Administration (FDA) plays a crucial role in regulating and overseeing chemical registration.
- February 7, 2024 Pharmacovigilance, Regulatory Medical WritingPharmacovigilance is a critical field in healthcare that focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. A cornerstone of pharmacovigilance is causality assessment, which is the systematic evaluation of the evidence to determine whether a drug caused a particular adverse event.
- February 7, 2024 Pharmacovigilance, Regulatory Medical Writing
Traditionally, literature surveillance has been an effort-intensive process, requiring pharmacovigilance specialists to manually search, review, and analyze vast amounts of published/ unpublished data for potential adverse events (AEs) and safety-related information. However, Artificial Intelligence (AI), with its machine learning (ML) and natural language processing (NLP) capabilities, is changing the game.
- January 31, 2024 Publishing & Submissions, Regulatory Intelligence, Regulatory Software & Services
As we blast off into 2024, the life sciences industry is about to undergo a radical metamorphosis - not just a facelift, but a full-on cyborg upgrade. Regulatory affairs are set to morph into a sleek, interconnected beast, fueled by cutting-edge technology and global collaboration. Buckle up, because these five trends are about to reshape the entire game:
Unlocking the Synergy: Digital Health Technologies and Regulatory Mastery in Clinical Investigations
January 24, 2024 Pharmaceuticals, Regulatory Medical WritingThe integration of Digital Health Technologies (DHTs) heralds a transformative era in the realm of clinical investigations. From computing platforms to wearables, these technologies redefine the landscape, offering an innovative lens for evaluating medical products.
- January 24, 2024 Pharmaceuticals, Regulatory Medical Writing
Good clinical practice (GCP) and good laboratory practice (GLP) are quality standards that ensure the safety, reliability, and integrity of clinical trials and laboratory studies. GCP and GLP monitoring and audit are essential activities to verify compliance with these standards and identify any gaps or issues that need improvement.
- January 23, 2024 Medical Devices, Regulatory Affairs
Navigating the complex landscape of the US Food and Drug Administration (FDA) pre-market submissions can be a daunting task for medical device manufacturers. Understanding the different types of submissions, their specific requirements, and the submission process is crucial for a successful market entry.
- January 23, 2024 Medical Devices, Regulatory Affairs
The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA).
- January 22, 2024 Medical Devices, Regulatory Affairs
Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent.