Testing plays a crucial role in the cosmetic product manufacturing process. Compliance with specific testing requirements is essential to ensure that cosmetic products are safe for use under reasonably foreseeable conditions. To uphold the strict Regulatory standards and protect consumers, cosmetic testing in the European Union (EU) involves a comprehensive process of assessment and evaluation.
- August 28, 2023 Cosmetics Regulatory Services, Regulatory Affairs
- August 28, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Colombia is a vibrant market for cosmetic products, with a growing consumer base that places a strong emphasis on personal care and beauty. To ensure the quality and safety of cosmetic products sold in the market, Colombia has established a Regulatory framework with specific requirements.
- August 28, 2023 Medical Devices, Regulatory Affairs
The advancement of medical devices has revolutionized patient care and treatment outcomes.
- August 28, 2023 Publishing & Submissions, Regulatory Intelligence
Navigating the Regulatory landscape can be a complex and time-consuming process for pharmaceutical and biotechnology companies.
- August 28, 2023 Publishing & Submissions
In April 2022, the United States Food and Drug Administration (US FDA) took a significant stride toward modernizing the Regulatory process by releasing guidance on the electronic submission of promotional materials for human prescription drugs.
- August 28, 2023 Medical Devices, Regulatory Affairs
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions.
- August 28, 2023 Medical Devices, Regulatory Affairs
Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization.
- August 28, 2023 Medical Devices, Regulatory Affairs
The previous blog on the Fast-break Scheme (Part 1) discussed Japan’s conditional early approval system for innovative medical devices, covering four (04) essential steps, the rationale and requirements for the application review process, the eligibility criteria, the application submission process, the MHLW and PMDA’s Regulatory guidelines, the review process, eligibility without pre-development consultation, and the key…
- August 28, 2023 Pharmaceuticals, Regulatory Artwork Services
In the fast-paced and highly regulated pharmaceutical industry, maintaining brand integrity is a fundamental building block of success. As pharmaceutical companies strive to deliver safe and reliable products, packaging artwork emerges as a crucial element in ensuring brand identity and compliance with Regulatory standards.
- August 28, 2023 Medical Devices, Regulatory Affairs
Literature reviews play a crucial role in the clinical evaluation of medical devices and In Vitro Diagnostics (IVDs) throughout their entire lifecycle. These reviews enable researchers to examine previous studies, build upon existing knowledge, and contribute meaningfully to their respective fields.