The pharmaceutical industry is a complex and highly regulated field where patient safety and product integrity are paramount. The packaging of pharmaceutical products is a critical element of this industry, as it ensures that medications remain effective and safe from the moment, they leave the manufacturer until they reach the patient's hands.
- December 15, 2023 Pharmaceuticals, Regulatory Artwork Services, Regulatory Affairs
- December 15, 2023 Pharmaceuticals, Publishing & Submissions
Submitting a Marketing Authorization Application (MAA) to multiple Regulatory authorities can be a complex and time-consuming process, especially when it involves submitting the same Active Substance Master File (ASMF) to each authority. This is because different Regulatory authorities may have different requirements for ASMF submissions.
- December 14, 2023 Medical Devices, Regulatory Affairs
Introduction
The In Vitro Diagnostic Medical Devices Regulation (IVDR) ensures the safety and efficacy of In Vitro Diagnostic (IVD) medical devices, which include test kits, reagents, and equipment for diagnosis and monitoring of diseases. To place an IVDR medical device in the European market, manufacturers must obtain CE marking.
- December 13, 2023 Pharmaceuticals, Regulatory Affairs
The South Korean pharmaceutical industry is one of the most dynamic and innovative industries in Asia. The country is strongly committed to Research and Development(R&D), and its Regulatory framework is designed to facilitate the development and approval of new drugs.
- December 13, 2023 Medical Devices
When a foreign establishment engages in the production of a medical device imported into the United States (US), it is mandatory to designate a US agent for that establishment. The US agent serves as the point of contact for any US Food and Drug Administration (US FDA) communication related to the foreign registered facility.
- December 7, 2023 Medical Devices
What is Data Privacy in Healthcare?
Healthcare data includes technologies and systems used for creating health information that is accessible to patients and healthcare providers. It allows doctors to access vital patient information and enables hospitals and other physicians to protect patient data and build trust with patients.
- December 6, 2023 Medical Devices
Telehealth is the use of technology to provide services such as consultations, diagnosis, treatment, and remote monitoring. It has emerged as a prominent trend in healthcare over the years and was especially relevant during the outbreak of COVID-19. The telehealth sector is thriving today, and it is expected to grow in the coming years.
- December 6, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the pharmaceutical industry, regulatory compliance is not just a necessity; it's a cornerstone for ensuring the safety and efficacy of drugs. With technology evolving at an unprecedented pace, the integration of computer software in quality control and assurance processes has become a game-changer for pharmaceutical companies striving to meet and exceed regulatory standards.
- December 6, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the dynamic landscape of the pharmaceutical industry, data integrity plays a pivotal role in ensuring safety, efficacy, and quality of the products. As regulatory agencies continue to tighten their scrutiny, it is imperative for pharmaceutical companies to adopt robust measures to guarantee the integrity of their data.
- December 5, 2023 Regulatory Affairs
In the pharma Regulatory arena, the ICH guidelines alongside the health authorities play a pivotal role in ensuring drug product safety and efficacy. However, with the global reach of the pharmaceutical industry, harmonizing Regulatory standards across diverse regions has become a critical imperative.