Everything you need to know about FDA Regulatory Consulting
The Food and Drug Administration (FDA) is a regulatory agency that oversees the safety of food, drugs, medical devices, and biological products. It has two primary functions: to regulate products before they are marketed in the U.S., and to enforce compliance with regulations after product marketing has occurred. The FDA does not approve or test any products; it only provides oversight for regulation compliance once a company has submitted their product for review.
Regulatory consultants are experts that can help you build your business by providing the right solutions to comply with local, global, and regional health regulations, such as those required by the FDA. They have professional staff that provides targeted assistance for your company’s needs, both now and in the future.
In this article, you’ll discover 5 quick facts about serving FDA Regulatory Consulting. Check them out below:
1- What is Regulatory Consulting?
Regulatory consulting is a process that allows companies to receive expert advice on areas that impact development of a product or their marketing processes. Consultants provide support on all aspects of government regulations and standards for medical devices, drugs, biological products, or food formulations. Regulatory consultants also provide advice to meet special requirements in regulated jurisdictions when carrying out market research and developing clinical trial plans.
2- What is the FDA?
The Food and Drug Administration (FDA) is the main governing body in the US that is in charge of regulating everything related to food and drug ingredients. This includes chemicals in foods and ensuring the safety, efficacy, and security of drugs.
3- Do all companies need FDA approval?
No. In the US, on a federal level, there are certain industries that don’t fall under FDA regulation on a case-by-case basis, such as food and beverage manufacturing for animals. Other organizations, like NSF International or BRC Global Standards, serve as alternatives for certification against food safety standards.
Even though lack of FDA enforcement doesn’t mean it’s safe to produce unregulated products, many companies still do this anyway. One reason is to avoid heavy costs that may be associated with adhering to stringent rules and regulations. Another reason is because some companies want their product’s claims unconfirmed, thus avoiding liability problems regarding statements made about their product. Regulatory consultants can provide advice related to these and other ethical considerations that might arise when navigating the waters of product regulations.
4- How much does an FDA consultant cost?
An FDA consultant, usually an individual experienced with the industry that possesses a keen understanding of the federal agency, can cost anywhere from $100 to $150 per hour. Most consulting fees are quoted on a project-by-project basis. All consultants have their own hourly rates because there is no standard rate for this type of work.
5- What are the ways to get FDA approval?
There are several different ways you can get your product approved by the FDA, including: 1) Pre-Approval Inspections; 2) New Drug Application (NDA); 3) Abbreviated New Drug Application (ANDA); 4) Biologics License Application (BLA); 5) De Novo Requests; and 6) Investigational New Drugs (INDs). An experienced regulatory consultant can help your company to determine which approval route is the right one for your situation.
In conclusion, regulatory experts are trained professionals who can help you navigate the regulatory environment so your company is compliant with local and federal regulations. Their knowledge related to local, global, and regional health regulations will help your company maintain compliance in all situations. Whether you want advice about a new product or business strategy that includes an innovative ingredient not yet approved by regulators, or you need help finding the right solution to comply with laws around the world, consultants are there to answer all of your questions quickly and accurately – just contact them now!