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
- 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.
- 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.