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.
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.
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 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.
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.
Is good , simplified and must know summary where in RA teams and SMEs role in Pharma business
ReplyDeleteI just want to say they are interface between regulatory agencies, industry and quality management systems of organisation
As indicated they navigate, regulate , guide and read between the lines to present case to organisations systems, regulators from stage of registration to approval and deal with emotions of teams operating various systems and data management among teams internally and stand as fa face of organisation
Good role of advocating and perceiving with all at all stages of development to marketing and bringing joy to organisation and team for there contribution 👍🙏
More and more knowledge from such types of blogs is great. I am a thorough reader of such blogs and this has helped me a lot.
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