ISSN
2249-7633
e ISSN
2249-7625
Publisher
Pharmacy Practice & Drug Research
FIRST REQUIREMENT FOR THE APPEAL OF ANTICANCER DRUG SUBMISSION PROCESS IN USA & EUROPE
Author / Afflication
Nagabhushanamma G
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.
Ramesh Reddy K
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.
Umasankar K
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.
Alagusundaram M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.
Jayachandra Reddy P
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.
Keywords
Regulatory Affairs ,Oncology , Common Technical Document ,New drug ,
Abstract
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements - all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs department ensures that their companies comply with all of the regulations and laws concerning their business. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.
Volume / Issue / Year
5 , 2 , 2015
Starting Page No / Endling Page No
59 - 77