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Pre-market Quality/Regulatory Strategies in Drug/Device Development

BayBiotech.NET
A well planned regulatory strategy in the initial phase of product development is an essential component to safely and effectively launch the FDA regulated product in the market. However, preparing an effective strategy leading to commercialization of the product depends on many factors and one of the most important factor is to determine the class and subcategory of the product to be developed.

For example if you plan to develop a drug, then must subcategorize it as over-the-counter, new drug, generic drug etc. Once the class and subcategory is identified, then local, state, federal and international guidelines must be reviewed thoroughly for understanding the regulatory needs for the particular class and subcategory of the product. Next step followed will be to prepare a risk/ benefit analysis and targeted pre-clinical experiments to demonstrate the safety and efficacy of the product as well as developing different protocols for procurement, experimental procedures and identifying resources for the quality supplies.

It is the responsibility of the Quality Assurance and Regulatory personnel to ensure that all the protocols and procedures in the development stages are prepared as per GLP and GMP guidelines. It is also the responsibility of the QA/RA personnel to keep the higher management informed about the compliance issues and ensure to work with them to rectify the problem areas for a smooth future marketing of the product.

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