In the pharmaceutical industry, labeling errors can have serious consequences, ranging from jeopardizing patient safety to Regulatory non-compliance. Therefore, companies must prioritize error-free labeling to maintain compliance and uphold the highest quality and safety. In the following lines, let us further delve into the importance of error-free labeling and how companies can accomplish the same.
- January 12, 2024 Pharmaceuticals, Regulatory Labeling
- January 9, 2024 Pharmaceuticals, Regulatory Affairs
In January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched the Accelerating Clinical Trials in the EU (ACT EU) initiative. This initiative consists of ten suggested actions for sites, sponsors, and clinical research organizations (CROs) to take over the next three years, leading up to the full implementation deadline in January 2025.
- January 9, 2024 Pharmaceuticals, Publishing & Submissions
The evolution of the electronic Common Technical Document (eCTD) format has reached a critical stage with the introduction of eCTD 4.0. This latest version promises significant improvements in efficiency, data integrity, and accessibility for Regulatory submissions. Lifecycle enhancements and study tagging are two key features of eCTD 4.0 that can greatly benefit sponsors and Regulatory affairs professionals.
- January 9, 2024 Pharmaceuticals, Publishing & Submissions
Ensuring a smooth and efficient Investigational New Drug (IND) Lifecycle Management (LCM) submission requires meticulous planning and attention to detail. One crucial aspect is the compilation and publishing of your submission package. The process demands a high level of accuracy and compliance with regulatory standards.
- January 9, 2024 Pharmaceuticals, Compliance, Audit and Validation
In the pharmaceutical industry, ensuring the safety and efficacy of drugs doesn't end with Regulatory approval. Post-market surveillance emerges as a pivotal phase in public health. This blog explores its critical role and the Regulatory compliance measures that pharmaceutical companies must adopt in the post-approval stage.
- January 9, 2024 Pharmaceuticals, Regulatory Affairs
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
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.