Department of Pharmaceutics and drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

Department of Pharmaceutics and drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

Department of Pharmaceutics and drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.
Regulatory ,DRA ,USFDA ,EUDRA ,RAPS ,DIA ,Registration ,Communications ,

The pharmaceutical research and development process of bringing a new drug to the market takes many years,In today‟s competitive environment the reduction of the time taken to reach the market is critical to a product‟s and hence the company‟s success. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.The drug regulatory affairs (DRA) professional plays an important role in every phase of this process, from developing regulatory strategies following the discovery of a new chemical entity to planning post-marketing activities Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking.Worldwide regulatory agencies such as USFDA1 (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA). A number of organizations such as the Regulatory Affairs Professional Society (RAPS), the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI) and international organizations such as the European Society of Regulatory Affairs play a vital role in providing relevant information. The main objective of the work is to evaluate pre and post registration of “MONTELUKAST CHEWABLE TABLETS” filled in various countries so as to reduce the risk of regulatory delays and to reduce the registration lead time.Based on the experience gained from this product registration countries regulatory filing strategy has been developed to improve the quality of the submission file which helps to reduce the number of deficiencies received from each regulatory authority. It also helps to reduce the product registration lead time which allows commercial team to launch the product at the earliest.

5 , 2 , 2015