Volume : 12, Issue : 10, October – 2025
Title:
INTER RELATIONSHIP BETWEEN RA, QA AND QC FOR REGULATORY AFFAIRS
Authors :
Gunde Navitha*, Mrs. M. Mounika, Dr. D. Venkata Ramana.
Abstract :
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. There are different departments in pharmaceutical company such as Research and Development, Quality Assurance, Production, and Quality Control. RA officer having different roles in these departments. They are involved in the development of new medicinal products from the primary stage, preparing the dossier and documentation to till end stage, submitting the relevant regulatory dossiers to health authorities. In this review we discussed that the role of RA officer in different areas discussed. RA is also responsible for maintaining the appropriateness and accuracy of the product information. And its main role to act as a liaison with regulatory agencies, providing expertise and regulatory intelligence in translating regulatory requirement into practical workable plan , advising the company on regulatory aspects and climate that would affect their proposed activities for the purpose of regulatory submission.
Key words: Research and Development, Quality Assurance, Production, and Quality Control, regulatory submission.
Cite This Article:
Please cite this article in press Gunde Navitha et al., Inter Relationship Between RA, QA And QC For Regulatory Affairs, Indo Am. J. P. Sci, 2025; 12(10).
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