UNIT 6
Regulatory Framework
INTRODUCTION
Firms that produce medicines, medical devices, food supplements and veterinary medicines have to ensure compliance with all regulations and laws concerning business. Regulations are the rules established by an agency that interprets the laws to facilitate their practical implementation. Pharmaceutical firms need to ensure adherence to established regulations and a vital communications link with regulatory agencies for (a) new product development processes, (b) distribution of drugs in different geographical locations, (c) following up with issued advisory related to constraints and regulatory requirements, ...
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