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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | SIGNIFICANCE OF PHARMACEUTICAL REGULARLY BODIES |
| Authors Name: | K.Malleswari , D. RamaBrahma Reddy , N.Gouri |
| Unique Id: | IJSDR2301180 |
| Published In: | Volume 8 Issue 1, January-2023 |
| Abstract: | The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The Pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory Authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug Development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of Pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is Essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes the development of the drugs as it is a cumbersome process which includes several months Of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated As per the norms and regulations as given by those individual countries to carry out the drug development which Was generally governed by the Drug Regulatory Affairs Personals. |
| Keywords: | Regulatory bodies, Product life cycle, Regulated industries, Regulatory environment. |
| Cite Article: | "SIGNIFICANCE OF PHARMACEUTICAL REGULARLY BODIES", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 1, page no.1126 - 1131, January-2023, Available :http://www.ijsdr.org/papers/IJSDR2301180.pdf |
| Downloads: | 000337067 |
| Publication Details: | Published Paper ID: IJSDR2301180 Registration ID:203731 Published In: Volume 8 Issue 1, January-2023 DOI (Digital Object Identifier): Page No: 1126 - 1131 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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