The Objectives Of Regulatory Strategic Planning Essay examples

1496 Words Nov 19th, 2016 6 Pages
The main goal of Regulatory Strategic planning is to develop the drug, biologic or medical device and get marketing authorization as well as maintain post marketing authorization in preferred countries. A regulatory strategy is an official document that supports the regulatory happenings to offer a new product or improved an existing product. A regulatory strategy begins with the alliance with a cross functional team to recognize significant questions related to the product. All questions related to the new product will answer according to how is the product being used, what is the target population, does the new product is superior over the existing available product, in which countries’ the product can get approval, the product risk v/s benefits and product life cycle consideration. Regulatory Strategies are live document that is studied and modified as the project progresses.
Pharmaceutical products have really worldwide usage with different development activities. Clinical trials have been performed at many sites around the world for many years to obtain approvals in multiple countries. The harmonization of regulatory processes developed by the ICH, drug patent laws, and country specific regulations is very important steps towards the product development, such as drug discovery, early development and preclinical testing, clinical trials and marketing authorizations. Nearly every country agrees to accept the ICH technical necessities for registration of pharmaceutical…

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