Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned regulatory authority.
In 1937, Elixir Sulfanilamide which was marketed without any marketing testing caused deaths of more than 100 people in the USA. The pharmaceutical company added DEG as a solvent along with raspberry flavor for Sulfanilamide to be used as an elixir. This created an outrage and finally, led to the Federal Food, Drug and Cosmetic Act in 1938. However, the tragic incidents did not end there, there were many which led to various acts and amendments and one of the impactful being the “Thalidomide Tragedy”. The drug thalidomide was given to pregnant women to control morning sickness, however, it was late until it was realized that children were born with phocomelia because of the drug intake, and a major amendment was made to the Federal Food, Drug, and Cosmetic Act in 1962.
With this comes the need of Regulatory Affairs Consultants who are responsible for the protection and safety of human health; ensure the safety, efficacy, and quality of drugs; and ensure that the product is intended for use only where it is appropriate. To fulfill these goals:
• Regulatory Affairs Consulting Services work as per the guidelines of regulatory agencies, prepare and compile documents like NDA, ANDA, INDA, MAA, and DMP that are required by regulatory authorities.
• Make sure that all the processes involved comply and adhere to the applicable guidelines and regulations like cGMP, ICH, GCP, GLP, etc.
• Advice and strategize workable plans that would help the company to get its product into the market and at the same time abiding by the regulatory guidelines.
Hence, the general work profile of a Regulatory Affairs Consultant in a pharmaceutical company includes filing DMFs and dossiers, being up-to-date with any amendments that are released by regulatory authorities, and maintain and submit all the documents required for the approval of a drug to be marketed. To sum it up, it is the Regulatory Consultants who act as a bridge between a pharmaceutical company and regulatory authorities to get the product into the market.
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