4 Tasks For An FDA Regulatory Consultant
FDA regulatory consulting is necessary for many industries, including food production, drug manufacturing, and medical device design. You may want to hire an FDA regulatory consultant to help you with a number of situations. Organizations that need help with these four tasks ought to discuss their concerns with a consultant.
Assessing Applicable Standards
The fact that a product or process falls under FDA rules isn't all that informative in terms of what you need to you. After all, the FDA regulates products, services, and processes in many distinct industries. What applies on the food side might not apply on the drug side. Similarly, there are often questions of fine distinctions, such as the difference between a drug and a supplement.
An FDA regulatory consultant can study your company's products and services to assess what the applicable standards are. They can contact FDA regulators, explain what you're doing, and then help you decide how to comply with the applicable regulations.
Unsurprisingly, these processes tend to be document-heavy. Even if you've dealt with the FDA hundreds of times before, it's wise to have an independent party check your paperwork before you submit it. A consultant can help you identify which paperwork goes to the FDA for your purpose, spot potential problem areas, and assist you with entering the fields on the forms. If you need to submit written statements or diagrams, they also can assist you with presenting those supporting materials.
FDA regulatory consulting gets into the weeds, too. If you need to include research data from a challenging field like organic chemistry, a consultant can help you present the data as faithfully as possible while also making it accessible to regulators.
Audits and Inspections
The FDA also monitors facilities in most of the regulated industries. It is wise to conduct internal audits and inspections to stay ahead of the FDA's work. Surprise inspections can verify that your team is doing everything to the letter of the regulations. Audits can identify potential problem areas so you can fix them, too.
Compliance and Approval Strategies
Companies often have to navigate the FDA's compliance and approval processes. If you're bringing a product to market, you should have a plan for how you'll handle the FDA's scrutiny. Depending on the industry you're in, this could include multiple phases of testing over several years. Your goal is to bring the product to market smoothly and safely while exceeding the FDA's expectations.
For more info, contact a local company like Compliance Insight.