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(PDF) International Journal of Drug Regulatory Affairs ...
International Journal of Drug Regulatory Affairs Drug approval process in US, Europe and India and its regulatory requirements: A Review Article (PDF Available) · January 2018 with 438 Reads
REGULATORY PROCESS FOR IMPORT AND EXPORT OF DRUGS IN INDIA ...
This article mainly focuses on the approval process of drug import and export from India. Now a day’s foreign pharmaceutical companies have a better legal foundation for releasing new drugs in India. The Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing....
Regulatory Affairs - an overview | ScienceDirect Topics
Toby Freedman PhD, in Biotechnology Entrepreneurship, 2014. 8 Regulatory Affairs. Regulatory affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)....
(PDF) A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND ...
Vishal et al. International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11 ISSN: 2321 - 6794 A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA Available online at www.ijdra.com REVIEW ARTICLE 1 Prajapati Vishal*, 1Goswami Rahulgiri, 1Makvana Pratik, 2Badjatya Jitendra Kumar 1 L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.
 REGULATORY ROADMAP FOR NANOTECHNOLOGY BASED MEDICINES
specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.
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