What is Regulatory Affairs?
Regulatory affairs is a term used to describe the process of ensuring that a drug or medical device is safe and effective for use by humans. The regulatory affairs function includes many different roles and responsibilities, including clinical research, product approval, labelling/marketing/promotion, quality assurance, and post-market surveillance.Regulatory Affairs professionals work in both the pharmaceutical industry and medical device industry. Regulatory Affairs professionals are responsible for ensuring that all products are manufactured according to FDA standards. They also ensure that all promotions adhere to FDA regulations as well as any other applicable laws and regulations. Regulatory Affairs professionals also monitor the safety of products after they have been approved by the FDA to make sure they remain safe for consumers.
Uses of Regulatory Affairs in the Industry
Regulatory Affairs is an important function in the pharmaceutical industry. It ensures that a drug or medical device is safe and effective for use in humans. The regulatory affairs department reviews clinical data, conducts research, and communicates with regulatory agencies to ensure that a product is safe and effective for the intended use of the product. Regulatory affairs professionals have a number of responsibilities including: communicating with regulatory agencies on behalf of their company, interpreting regulations, monitoring legislative changes to legislation governing their products, ensuring compliance with regulation requirements, and providing advice to management on risk-management strategies.
Regulatory Affairs in the Covid-19
Regulatory Affairs is an important function in the pharmaceutical industry. It ensures that a drug or medical device is safe and effective for use in humans. The regulatory affairs department reviews clinical data, conducts research, and communicates with regulatory agencies to ensure that a product is safe and effective for the intended use of the product.
Regulatory affairs professionals have a number of responsibilities including: communicating with regulatory agencies on behalf of their company, interpreting regulations, monitoring legislative changes to legislation governing their products, ensuring compliance with regulation requirements, and providing advice to management on risk-management strategies.
Circes for Regulatory Affairs Professionals Circes is the first regulatory affairs AI assistant. It uses natural language processing, machine learning, and deep learning to provide regulatory compliance professionals with a seamless and intuitive experience.
Drug Regulatory Affairs (R&D) professionals are tasked with ensuring that pharmaceutical companies produce drugs that are safe for human consumption. They have to not only comply with regulations but also ensure that these regulations are met in an efficient way. Circes aims at providing these professionals with an AI assistant which will help them in their day to day tasks by making it easier for them to understand the regulatory landscape, stay up-to-date on regulations, and automate repetitive tasks.
