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.
What Is a Regulatory Consultant?
As a quick reminder, the Food and Drug Administration (FDA) regulates medical devices along with food, drugs (including dietary supplements), cosmetics, tobacco products and electronics that give off radiation.
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.
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.
How Do FDA Regulatory Consultants Work?
At A Wright Path, weâ€™ll 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 youâ€™re 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.
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.
Times to Hire an FDA Regulatory Consultant
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.
Introducing a New or Modification of a Product (Medical Device, Drug, or Combination Product)
A consultant knows regulatory requirements and will lead you to bring your product to market. There are a lot of steps during the regulatory pathway; an FDA consultant makes the whole process easier.
If You Receive FDA Warning Letters or 483
General warning letters sent by the FDA are due to regulation violations, so warning letter responses should be done as fast as possible. Included in the correspondence is the violation, how you will correct the issue, and a timeframe in which the remediation needs to be completed.
An FDA Inspection
Another important time to hire a regulator consultant is if you are facing an FDA inspection. During an inspection, FDA compliance is reviewed to Quality Systems Regulations (21 CFR Part 820) and other regulations. These occur as part of a routine schedule or after a problem is reported. The FDA encourages companies to know and understand how an on-site FDA inspection works to help with the process.
Hiring the â€śWrightâ€ť Consultant
When beginning your search for an FDA regulatory consultant, the following is a list of questions to ask yourself and about the consulting firm.
- Does the consultant understand regulatory submissions and how to maintain regulatory compliance? For example, do they have experience submitting a 510(k), PMA, De Novo submissions to the FDA, and what was the outcome? Are they familiar with good manufacturing practices (GMP) and standard operating procedures (SOP) for medical device companies?
- Do they participate in webinars and other training to have the most updated knowledge as outlined by the FDA?
- How extensive is their background working within FDA-regulated industries? Are there client references they can provide that you can verify their performance?
Ready to Hire an FDA Regulatory Consultant?
So, are you in need of an FDA regulatory consultant? A Wright Path will help you bring your medical device to market with as few hurdles as possible and following FDA regulations. Once the approval process is complete, we can continue to ensure manufacturing and marketing practices are in FDA regulatory compliance. Contact us today to schedule a consultation.