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 …
Production Department in Pharmaceutical Industry Production Department-The process of Drug Manufacturing performed in Production Department in Pharmaceutical Unit into a series of unit operations, such as dispensing, granulation, coating, tablet pressing, blistering, mixing, filling, and others. Table of Contents Production General Process Air Flow Pattern Under LFA in Aseptic Processing SOP: This SOP outlines the …
How SAS v4 using For Bioequivalence Data analysis SAS Bioequivalence data analysis-SAS SAS is commonly employed in the analysis of bioequivalence (BE) data. On the other hand, R, a freely available open-source software for general-purpose data analysis, sees less frequent use than SAS in BE data analysis. This tutorial elucidates the utilization of R for …
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 PHARMACEUTICAL ENGINEERING? Pharmaceutical Engineering & Designing of Drug-2024 : The origins of pharmaceuticals can be traced back to the 1500s, marked by the creation of the first list of drugs and their preparations in Germany. Since that time, pharmaceuticals have become integral to medical care, playing a crucial role in preventing and treating …
Labeling and packaging in regulatory affairs? Labeling and packaging role in regulatory affairs: Labeling and packaging play a crucial role in regulatory affairs, adding artistic elements to product presentation while serving as essential components in compliance. This involves the creation and maintenance of labels and packages that meet regulatory standards and effectively communicate necessary information …
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 Statistical-analysis-system (SAS) in Clinical SAS What-is-statistical-analysis-system (SAS)-procedures encompass prewritten programs designed to execute specific tasks. Noteworthy procedures, such as PROC MEANS for summarizing statistics, PROC FREQ for frequency analysis, and PROC REG for regression analysis, find common usage. Data Your Output Data Set; set Your Input Data Set; IF-THEN statements facilitate conditional processing …