Quality Risk Management Approach for Drug Development and Its Future Prospectives

Muthukumar Subramanian; Keshamma E.; Deepika Janjua; Devinder Kumar; Roshan Kumar; Purabi Saha; Rakesh Kumar Gupta; Shuaib Rao

doi:10.55544/jrasb.1.3.22

Authors

Dr. Muthukumar Subramanian SRM Institute of Science & Technology, Tiruchirappalli Campus, Deemed to be University, Tamilndu, INDIA.
Dr. Keshamma E Associate Professor, Department of Biochemistry, Maharani Cluster University, Palace Road, Bangalore-560001, INDIA.
Deepika Janjua Department of Pharmacy, Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun -248007, Uttarakhand, INDIA.
Devinder Kumar Assistant Professor, Department of Pharmacology, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmcy, Bela, Punjab, INDIA.
Roshan Kumar Research Scholar, Department of Pharmacology, Dev Bhoomi Institute of Pharmacy and Research, Dehradun-248007, Uttarakhand, INDIA.
Purabi Saha Department of Pharmacy, Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun -248007, Uttarakhand, INDIA.
Rakesh Kumar Gupta IIMT College of Pharmacy, Knowledge Park III, Greater Noida, Uttar Pradesh 201310, INDIA.
Shuaib Rao Department of Pharmacy, Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun -248007, Uttarakhand, INDIA.

DOI:

https://doi.org/10.55544/jrasb.1.3.22

Keywords:

FDA, Regulatory Affairs, ICH, Pharmaceutical Companies, New drug Approval (NDA)

Abstract

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional.

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References

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