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Tag Archives: Biological products

A Comparative Study of Biological Products Regulations in USA, CANADA, AUSTRALIA, EUROPE, SINGAPORE and INDIA

Kullanivagaira Kumari1, K. Sunil Kumar*2 1Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. 2Associate Professor, Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India A  B S T R A C T The FDA is an agency in the US Department of Health and Human Services ... Read More »

Regulations and Management of Biological Products

B. Abhirami*, C.P. Sreekanth Reddy1, J. Praveen kumar2, E. Vijay Kumar3 *Krishna Teja Pharmacy College, Tirupati, A.P. 1Assistant Professor, Krishna Teja Pharmacy College, Tirupati, A.P 2Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P 3Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P ABSTRACT The regulation of the biological and biotechnological products constitutes a significant challenge, since they are part of ... Read More »

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