{"id":1036,"date":"2022-09-01T11:34:40","date_gmt":"2022-09-01T16:34:40","guid":{"rendered":"https:\/\/awrightpath.net\/?p=1036"},"modified":"2023-02-03T11:37:50","modified_gmt":"2023-02-03T16:37:50","slug":"whens-the-right-time-to-hire-an-fda-regulatory-consultant","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/whens-the-right-time-to-hire-an-fda-regulatory-consultant\/","title":{"rendered":"When’s the Right Time to Hire an FDA Regulatory Consultant?"},"content":{"rendered":"

It is important to hire an FDA regulatory consultant in the early stages of product development to make sure the roadmap to FDA approval is as easy as possible. By bringing a regulatory expert on board, the chances of errors in regulatory affairs are reduced. Learn more about what an FDA consultant is and the regulatory services they provide.<\/p>\n

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What Is a Regulatory Consultant?<\/h2>\n

As a quick reminder, the Food and Drug Administration (FDA) regulates<\/a> medical devices along with food, drugs (including dietary supplements), cosmetics, tobacco products and electronics that give off radiation.<\/p>\n

A regulatory consultant can work as part of a consulting firm, which can often include industry experts or former FDA employees. They help your company develop a regulatory strategy to get your product to market with as little disruption as possible.<\/p>\n

An FDA regulatory consultant helps define the information needed for FDA pre-submissions and FDA regulatory submissions, FDA device classification, FDA registration and product listings, and a regulatory strategy to get your product to market. They also provide companies with developing and maintaining Quality Systems (QMS) to meet FDA GMP requirements and product development testing required for FDA submissions.<\/p>\n

How Do FDA Regulatory Consultants Work?<\/h2>\n

At A Wright Path<\/a>, we\u2019ll help you determine your regulatory pathway and determine regulatory compliance. Hiring an FDA regulatory consultant is the easiest way to get your device to market, whether you\u2019re introducing a new product to the market (medical device, new drug, combination product), need a new or modified QMS, FDA inspection support, or clinical trial strategy. Also, A Wright Path offers post-market activities such as remediation or amending an existing product and follow-up regulatory submissions or letters to file.<\/p>\n

Ideally, your FDA regulatory consultant will have experience developing a regulatory strategy, developing and\/or maintaining a QMS for FDA compliance, and submitting the appropriate regulatory submissions.<\/p>\n

Times to Hire an FDA Regulatory Consultant<\/h2>\n

There are a handful of times to seek assistance from an FDA regulatory consultant. Below are some instances where it is useful to have consulting services.<\/p>\n