Regulatory affairs is a comparatively new business administration function. These departments can be found in a variety of companies that manufacture pharmaceuticals, drugs, medical devices, cosmetics and industrial chemicals. The Organisation for Professionals in Regulatory Affairs explains on its website that a regulatory affairs department ensures that the firm adheres to state and federal laws protecting public health. TOPRA is a professional association for people working in the field.
Oversight of Full Product Life Cycle
A department of regulatory affairs is primarily charged with the oversight of the product development cycle. The Regulatory Affairs Professionals Society says that the scope of this business function ranges from the start of product research and development right up to the post-marketing stage of the process, including the plans to test the product before it’s ready for market. The department also arranges consultations and meetings between the firm and government regulatory agencies. The regulatory affairs team compiles briefing documents for the government agencies as well. The team will also manage communication between the external regulatory agencies and the manufacturer.
Ensuring the Product Development Program Is Compliant
According to Pharmatching.com, the regulatory affairs team will develop the company’s regulatory strategy and integrate legal constraints into product development plans. The Biotransapp website reports that at this stage of the product life cycle the department will have to resolve compliance issues like the types of ingredients or chemicals that are permitted in products or the testing that is required.
Ensuring the Product Marketing Campaign Is Compliant
Before the product is marketed, the regulatory affairs department has to submit a new drug application to the public regulatory agency. In this submission it is also responsible for full disclosure of all scientific papers and data and also disclosure of data formats and collection procedures. Additionally, it will be responsible for providing the strategic regulatory framework for the submission. Balanced with this duty of compliance, the department has to be efficient and minimize the lead time in bringing its firm's product to market. To be effective, it needs to know all regulatory requirements and tests thoroughly. Failure at any point in this process can lead to costly delay in reaching the market.
Ensuring Post-Marketing Product Is Compliant
Once the product obtains marketing authorization, the department will also be tasked with keeping it. The U.S. Food and Drug Administration says that sometimes product safety issues don't surface until it's being used by consumers. The FDA works works with the regulatory affairs department to ensure that any dangerous side effects from products are identified quickly and if necessary recalled from the market. A recall will be issued by the department if there are problems with a product's packaging or manufacturing, or if it is contaminated.
- The Organisation for Professionals in Regulatory Affairs: What is regulatory affairs?
- The Regulatory Affairs Professionals Society: About the Regulatory Profession
- Pharmamatching.com: The Role and Responsibility of the Regulatory Affairs Department
- Biotransapp: Regulatory Affairs
- U.S. Food and Drug Administration: An FDA Guide to Drug Safety Terms
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