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Tag Archives: Regulatory affairs

Current Appraisal Procedures for New Regulations, Standards, Policies, and Guidance Issued by Regulatory Authorities

Kumari Sree lakshmi1, K. Sunil kumar2 1Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. 2 Associate Professor, Department of Pharmaceutics, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. ABSTRACT Regulatory Affairs Profession believe the new approach to regulation will eventually be adopted for all healthcare products as it represents the best model ... Read More »

An Evaluation and Comparative study of Regulatory Requirements for Registration of Generic Injectables in USA, European Union and Canada

Jaldu Praveen*, K Sreejan1, 2P. Jaya Chandra Reddy *1Krishna Teja Pharmacy College, Renigunta Road, Tirupathi. *2Principal Krishna Teja Pharmacy College, Renigunta Road, Tirupathi. A B S T R A C T Regulatory affairs professionals are key players in drug development to approve and through life cycle management of a drug. They are the primary communications link between the company and ... Read More »

An Evaluation and Comparative Study of Regulatory of Regulatory Requirements for Registration of Generic injectables in USA, European Union and Canada

D.S. Naveen Kumar*1, J. Praveen Kumar2 *1Krishna Teja Pharmacy College, Tirupati 2Associate professor, Krishna Teja Pharmacy College, Tirupati  A B S T R A C T Regulatory affairs professionals are key players in drug development to approve and through life cycle management of a drug. They are the primary communications link between the company and agencies such as FDA, MHRA, ... Read More »

A Comparative Study of Packaging, Labelling and Container Closure Systems of Various Regulatory Bodies

V. Narasimhulu*, J. Praveen Kumar, P. Jaya Chandra Reddy Krishna Teja Pharmacy College, Tirupathi, Andhra Pradesh, India ABSTRACT Regulatory affairs professionals are key players in drug development for obtaining approvals and maintaining life cycle management of both branded and generic drugs. Packaging has been around for many hundreds of years in some shape or form, from the early days of ... Read More »

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