Regulatory Pharma Blogs
How eCTD 4.0 implementation in Regulatory Affairs eCTD 4.0 – The electronic Common Technical Document (eCTD) is standardized guideline for submitting regulatory information to health authorities (HAs). It streamlines the process of electronically implementing the Common Technical Document (CTD). An eCTD comprises individual PDF documents organized hierarchically according to the CTD structure. Additionally, it features …
Regulatory response & Quality Trends for 2024 Regulatory response :ICH Q9 Quality Risk Management Regulatory response in 2023, significant changes have impacted drug manufacturers, particularly with the revised ICH Q9 guidance on quality risk management. This has prompted companies to reassess their quality risk management plans, ensuring their effectiveness in proactively addressing issues rather than …
What is Guidelines of TGA on Combination Products & Boundary 2024? TGA on Combination Products & Boundary guidelines TGA : What is Guidelines of TGA on Combination Products & Boundary, The Therapeutic Goods Administration (TGA), the Australian regulatory authority for healthcare products, has released guidance on boundary and combination products. The document offers insights into …
How To Submission Of ANDA To USFDA Regulatory, 2024 ANDA Application Submitting an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (USFDA) involves several key steps: 2024 Submission Of ANDA To USFDA Regulatory, 2024 ANDA Application Preparations and Research Submission Of ANDA To USFDA Regulatory How To Submission Of ANDA To …
What is Clinical Trials Phases in Clinical Research? clinical-trials-phase involve the examination of a new drug or treatment within a small group of healthy volunteers. The primary objectives include assessing safety, determining the dosage range, and identifying potential side effects. The goal is to understand the drug’s pharmacokinetics and pinpoint the maximum tolerated dose. Researchers …
What is Clinical Research & Clinical Trials? What is Clinical research is a specialized field within medical science dedicated to examining the safety and efficacy of medications, devices, diagnostic products, and treatment plans designed for human use. It plays a pivotal role in advancing medical knowledge, enhancing patient care, and fostering the development of innovative …
What is Regulatory Affairs, Compliance & Responsibility Regulatory affairs is a multifaceted field that involves the management and adherence to various regulations governing the development, production, and marketing of medical products. Professionals in this domain play a critical role in ensuring compliance with regulatory standards and guidelines set by governmental authorities. Their responsibilities span across …