Role of Regulatory Affairs in Pharmaceuticals : Pharmaceutical Guidelines

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Role of Regulatory Affairs in Pharmaceuticals

Regulatory affairs in pharmaceuticals has crucial role from applying new products to research and development of new drugs. It has various roles in manufacturing of pharmaceutical products.
Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers to use. In other words, regulatory affairs are in place to protect public health by evaluating the processes of drug discovery, production, and promotion of pharmaceutical products.

Regulatory affairs in the pharmaceutical industry comprise of a variety of functions. One of these functions includes staying abreast of the changes in the legislation of pharmaceutical drug research, manufacture, and marketing. This is a critical task as keeping updated on the rules and regulations of the pharmaceutical industry will govern the manufacturing and marketing practices of the pharmaceutical companies.
Regulatory Affairs in Pharmaceuticals

In addition, regulatory affairs are deeply involved in the collecting, collating, and compiling of scientific data for assessment in search of discrepancies or compromises in quality. This is often accomplished by gathering the numerous registration documents, which are organized into sections called Common Technical Documents, and consolidating it to form a dossier for each pharmaceutical product of a specific dosage and strength.

The consolidated dossier by regulatory affairs professionals will be submitted for review by regulatory agencies such as the FDA, or the Food and Drug Administration before authorization can be granted for the manufacture, marketing, and sale of the pharmaceutical product.

This aspect of regulatory affairs is undeniably the most important element of the job, as determines whether the pharmaceutical product will ever be released into the market. The collection, consolidation, and the compilation of the substantive scientific data and medical issues obtained from the clinical research and experimental trials conducted on the pharmaceutical drug takes up the lion's share of regulatory affairs.

Hence, it is quite evident that regulatory affairs are crucial in navigating the course of product development and product launches in the mammoth industry that is the pharmaceutical sector. Perched at a position where regulatory affairs can deliver vital strategic guidance and technical advisory to pharmaceutical multinational corporations, its work is integral for the scientific and commercial success of a pharmaceutical product, right from the conception of the idea at the stage of research and development, throughout the rigorous process of clinical trials, and finally onto marketing and branding before it sees the light of day.

Regulatory affairs are also paramount in protecting the pharmaceutical company from any liabilities of negligence or oversight, by ensuring the companies keep thoroughly meticulous documentation of clinical findings, scientific data, and accurate demonstrations of feedback on the efficacy and side effects of the drugs tested.

In addition, regulatory affairs extend its influence onto coordinating with various other regulatory agencies and departments to facilitate the submissions of proper and precise information for evaluation, so as to secure a swift and successful approval for the pharmaceutical products to penetrate and perform in the market. Hence, regulatory affairs are the language that the international drug regulatory ecosystem speaks and allows the communication between teams of multi-disciplinary individuals to facilitate the life cycle of pharmaceutical products.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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