Current Trends in Planning, Preparation and Delivering Regulatory Submissions


Authors : Tanya Bansal; Pallavi Uppal; Dr. Amrish Chandra,

Volume/Issue : Volume 8 - 2023, Issue 6 - June

Google Scholar : https://bit.ly/3TmGbDi

Scribd : https://tinyurl.com/eujc5yzh

DOI : https://doi.org/10.5281/zenodo.8073900

Abstract : Nurses in India have been making significant contributions in the planning and making informed regulations submissions with the help of medical documents relevant to authoritative principles, partnering with diverse teams and impositions related to quality development attributes. The introduction of this research gives an outline associated with this concern and approaches the importance of identifying these practices. This secondary research has followed an “explanatory research design”, incorporating peerreviewed journals. The authentic secondary sources of books, articles, and case reports have been incorporated based on the requirement. Thematic analysis has been considered which has provided an in-depth analysis of the problem statement. The devising and planning of authoritative submission have critically considered the “quality of life.” Regulatory body in Indian pharmaceutical industry “Central Drugs Standard and Control Organisation (CDSCO)” has been appointed for the regulation of drugs circulation in India. This paper highlights the findings related to cancellation of license of different companies related to unable to follow the proper norms of drug manufacturing. Additionally, recently, 48 drugs in India have been identified as out of necessary standard quality. The key purpose of the regulations is to maintain the quality for controlling the subject system, the process, or the products involved in the organisation. The main needs of the regulations are the improvisation of the regulatory body, jointly with the higher education authority, the Ministry of Health of the country, the higher education authority, and others. These are discussed in the study. Regulatory Submission is major essential aspect for recent times in case of pharma practice and thereby gaining the major rate of stability in drug delivery. Improvisation of the regulatory body, the Ministry of Health, jointly with higher education authority, higher education authority and other relevant aspects are involved as the needs in regulatory submission in pharma practice.

Keywords : Regulatory Submission, Pharma management, current practices, requirements of regulations, Ministry of Health.

Nurses in India have been making significant contributions in the planning and making informed regulations submissions with the help of medical documents relevant to authoritative principles, partnering with diverse teams and impositions related to quality development attributes. The introduction of this research gives an outline associated with this concern and approaches the importance of identifying these practices. This secondary research has followed an “explanatory research design”, incorporating peerreviewed journals. The authentic secondary sources of books, articles, and case reports have been incorporated based on the requirement. Thematic analysis has been considered which has provided an in-depth analysis of the problem statement. The devising and planning of authoritative submission have critically considered the “quality of life.” Regulatory body in Indian pharmaceutical industry “Central Drugs Standard and Control Organisation (CDSCO)” has been appointed for the regulation of drugs circulation in India. This paper highlights the findings related to cancellation of license of different companies related to unable to follow the proper norms of drug manufacturing. Additionally, recently, 48 drugs in India have been identified as out of necessary standard quality. The key purpose of the regulations is to maintain the quality for controlling the subject system, the process, or the products involved in the organisation. The main needs of the regulations are the improvisation of the regulatory body, jointly with the higher education authority, the Ministry of Health of the country, the higher education authority, and others. These are discussed in the study. Regulatory Submission is major essential aspect for recent times in case of pharma practice and thereby gaining the major rate of stability in drug delivery. Improvisation of the regulatory body, the Ministry of Health, jointly with higher education authority, higher education authority and other relevant aspects are involved as the needs in regulatory submission in pharma practice.

Keywords : Regulatory Submission, Pharma management, current practices, requirements of regulations, Ministry of Health.

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