In the ever-evolving world of pharmacovigilance, the EU is constantly seeking to strike a delicate balance between ensuring patient safety and fostering innovation. With their recent update to pharmacovigilance legislation which came into effect in July 2023. The spotlight falls on generics and biosimilars, raising important questions about risk management.
- January 9, 2024 Pharmaceuticals, Regulatory Affairs
- January 9, 2024 Pharmaceuticals, Regulatory Affairs
Mexico’s pharmaceutical industry is vibrant and growing, with strict regulations to ensure the safety and efficacy of drugs available to its citizens. Pharmaceutical companies aiming to bring their medicinal products to the Mexican market must carefully understand the drug approval process.
- January 5, 2024 Medical Devices, Regulatory Affairs
A quality agreement is a critical document in a medical device Quality Management System (QMS). The document should specify the responsibilities of various parties involved in activities that impact product quality, safety, and efficacy.
- December 29, 2023 Regulatory Artwork Services, Publishing & Submissions
As the curtains draw to a close on 2023, it's the perfect moment to pause and reflect on the year that it was, while eagerly anticipating what 2024 holds in store for us. The past year has been a testament to relentless evolution and groundbreaking strides in the ever-dynamic realm of life sciences.
- December 28, 2023 Pharmacovigilance, Regulatory Medical Writing
Bioanalytical reports are essential documents that present the results of measuring drug concentrations, metabolites, biologics, and biomarkers in biological matrices (e.g., blood, serum, plasma, saliva, urine, CSF, or tissue), an essential aspect of therapeutic product development. They provide the basis for pharmacokinetic and toxicokinetic evaluations and support regulatory submissions.
- December 15, 2023 Pharmaceuticals, Regulatory Artwork Services, Regulatory Affairs
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, 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.