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The Importance Of Regulatory Affairs

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A comparatively new profession, Regulatory Affairs essentially caters to the need for protection of public health by ensuring that the products developed are safe and efficacious. The discipline adds ethical and scientific values to the products and it is vital in making safe and effective healthcare products available worldwide. The core competency for regulatory affairs requires skilled and highly qualified professionals in order to carry out the niche activities involved.
The necessity of having resources with the niche skills and system that is essential for automation of various regulatory affairs activities is very high in order to stay in business. Additionally, the level of complexity involved and the need to be competent enough for …show more content…

The regulations keep on amending every now and then. Further, the interpretation skill differs from agency to agency and conflicts take place. The disputes between New Drug Application Holders and Abbreviated New Drug Application Holders are very common. The disputes over patent rights are also noticed many a times. It is very often observed that non-complying products get authorizations from the back door and the most complying products are refused the authorization on very minor issues.
The important organizations which support the profession are DIA, RAPS, and TOPRA. These organizations offer education and training, professional development, competence certification, and code of ethics. The most active agencies for developing and nourishing Regulatory affairs are US FDA, MHRA, EMEA, Health Canada, TGA, and WHO. Most of these bodies have their own regulations and standards for controlling the drug products.
Regulatory affairs require high degree of vigilance, good documentation skill, good manufacturing/distribution practices, precise scientific knowledge, and data integrity. Regulatory Affairs profession is continuously expanding. Currently the paper documents are getting replaced with electronic documents which are easy to review and store over a long …show more content…

Yet there is still scope for a lot of other non-operational activities that can be outsourced. However, there is a need for strategically apt steps to be followed while deciding on outsourcing the regulatory affairs activities in order to curb the cost involved and for resource crunch alleviation. An operating model along with outsourcing can be opted as a solution for cost reduction in a regulatory affairs function. Applying a strategic approach would ensure clarity about the high value activities thereby making partner selection easier and as per the required

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