A Review: Regulatory Affairs in Pharmaceutical Industry

Regulatory Affairs (RA) has emerged as an crucial field within industries concern to strict regulatory controls, with specific prominence in the pharmaceutical, biotechnology, and healthcare sectors. This evaluate article explores the multifaceted function of Regulatory Affairs professionals, who're instrumental in making sure compliance with complex regulatory frameworks while facilitating the secure, powerful, and well timed creation of health products to the marketplace. The obligations of RA encompass overseeing product lifestyles cycles, handling regulatory submissions, preserving safety and efficacy standards, and acting as key intermediaries among groups and governmental organizations. the article provides an indepth exam of regulatory our bodies throughout primary international regions, which include the vital tablets well known manipulate business enterprise (India), eu Directorate for exceptional of drug treatments and eu drugs enterprise (Europe), medicines and Healthcare products Regulatory enterprise (uk), healing goods management (Australia), prescribed drugs and medical devices corporation (Japan), fitness Canada, and the meals and Drug management (united states), highlighting their specific roles and contributions to public health safety.

Authors

Publication Details

Journal
International Journal for Research in Applied Science and Engineering Technology
Published
2025-05-08
DOI
https://doi.org/10.22214/ijraset.2025.70266
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

A Review: Regulatory Affairs in Pharmaceutical Industry

Mr. Karan Durge
International Journal for Research in Applied Science and Engineering Technology
Pharmaceutical Economics and Policy
article

A Review: Regulatory Affairs in Pharmaceutical Industry

Mr. Karan Durge
article en

Abstract

Regulatory Affairs (RA) has emerged as an crucial field within industries concern to strict regulatory controls, with specific prominence in the pharmaceutical, biotechnology, and healthcare sectors. This evaluate article explores the multifaceted function of Regulatory Affairs professionals, who're instrumental in making sure compliance with complex regulatory frameworks while facilitating the secure, powerful, and well timed creation of health products to the marketplace. The obligations of RA encompass overseeing product lifestyles cycles, handling regulatory submissions, preserving safety and efficacy standards, and acting as key intermediaries among groups and governmental organizations. the article provides an indepth exam of regulatory our bodies throughout primary international regions, which include the vital tablets well known manipulate business enterprise (India), eu Directorate for exceptional of drug treatments and eu drugs enterprise (Europe), medicines and Healthcare products Regulatory enterprise (uk), healing goods management (Australia), prescribed drugs and medical devices corporation (Japan), fitness Canada, and the meals and Drug management (united states), highlighting their specific roles and contributions to public health safety.

International Journal for Research in Applied Science and Engineering TechnologyVol. 13(5)
Openalex Percentile: Top 86%
Pharmaceutical Economics and Policy
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.