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

Kumari Sree lakshmi¹, K. Sunil kumar^2
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 for delivering new healthcare advances to market in a reasonable time with acceptable safety. Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory affairs professionals and Regulatory affairs department is constantly evolving the one which is least impacted during the acquisition and merger, and also during recession. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence within the company’s for their success and growth. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.
Keywords: Regulatory affairs, Health care products, Economic, Pharmaceutical Corporations