Regulatory Pharma Blogs
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 …
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 …