About FDACE PRO DO,
We offer trusted guidance and expertise so you can make the best decisions for your business.
At FDACE PRO, we pride ourselves on making sure our clients feel comfortable and empowered at every stage of our engagement. Our long-standing experience in the FDA. CE regulations enable us to offer you sound legal advice, so you can protect your business now and in the years to come.
Here’s what gives our clients and us a distinct advantage:
With over a decade of experience working with the FDA.
FDA legislation is intimidating and anxiety-inducing for many business owners.
We guide you through every stage, so you have peace of mind.
FDA, CE Marking Familiarity
We have built many connections within the FDA and CE. This helps us quickly connect with appropriate personnel to ensure our clients’ questions are seen and heard.
We serve a wide range of clientele in the food, dietary supplement: Beverage, cosmetic, medical device, and drug industries, located across in globe.
We are business owners too. This means we bring a unique perspective to the table, balancing the importance of gaining market share while meeting regulations.
Knowledge is power. We focus on offering expertise in understandable terms, so you feel confident about where your business is headed.
Our Areas Of Expertise
Getting drug products approved is a complex process. In many cases, OTC drugs need to be approved by the FDA before they are marketed. However, there are some exceptions.
If your products comply with the FDA’s OTC monograph regulations, you don’t need any FDA approval before marketing your products. However, they do need to be registered and the FDA.
The OTC monograph is a “recipe book” outlining which ingredients can be used and how. If you meet these requirements, then the drugs listed with are classified as GRASE, which stands for “generally recognized as safe and effective.”
If you sell homeopathic drugs, keep in mind that if they meet the new Compliance Policy Guide regulations, you don’t need FDA approval before marketing. However, the products will still need to be registered and listed with the FDA.
At FDACE PRO, we have extensive experience helping our global clients navigate the complicated FDA regulations around OTC and homeopathic drugs. Here’s how we can help:
Label and advertising review: We offer regulatory counseling to determine whether your product needs prior approval before marketing. Plus, we review tags and product packaging, in addition to marketing materials like ads, websites, and point-of-sale equipment, to ensure it’s all in compliance with FDA regulations.
Classification review: Confused about whether a product is a cosmetic, drug, or both? Wondering if an FDA monograph applies? FDACE PRO can guide you to the right answers through a classification review.
Adverse event reporting and record keeping: If there have been any adverse events related to your drug products, you’re required to report them to the FDA. We help clients develop standard operating procedures so you can quickly identify and publish the events, train your staff, and maintain compliance.
Export certificates: With all of the different export forms you need, how do you know you’ve got the right ones? As specialists in FDA regulation, We can help you identify the proper types, fill them out correctly, and ensure that your drug products don’t cause any issues at the border.
Feel confident knowing you’ve got an FDA expert on your side, looking out for your business.
To contact FDACE PRO and start the process.
Ensure your medical device attracts customers, not the FDA
If you’re developing, manufacturing, or marketing a medical device, you’ll need detailed knowledge of the FDA regulatory process. Everything from the way your machine is classified to how your product is cleared is complicated — and frequently confusing for business owners.
To be sure you have the right paperwork in place — and have provided FDA personnel with the correct information — it’s best to work with a regulatory expert who understands the legislation and can help you navigate it.
At FDACE PRO, we work with medical device clients all over the world, providing services in several areas:
Device classification: Is your medical device Class I, Class II, or Class III — or is it in more than one Class? You’ll need to know so you can plan and prepare your pre-market submission and regulatory paperwork. We offer product development counseling and assistance with determining product classifications.
Product clearance: Depending on your product class, you may need to file a 510(k) or other pre-market application for your device. We help you with any form, in addition to coordinating with investigators, research firms, manufacturers, and third-party reviewers to conduct necessary testing and analysis.
Label review: In addition to ensuring you have the right content on your labels, we provide it’s formatted according to FDA regulations. If your device requires specific instructions in the manual, like a hearing aid, for example, we help you figure out the right language to use.
Export certificate: Do you need to use Form 3616a or 3613b? What kind of export paperwork do you need? It’s overwhelming to figure out, but FDACE PRO can help. We make sure the right paperwork is filed so that the export process is smooth and worry-free.
Advertising review: When it comes to advertising your medical device, you not only have to follow FDA regulations, you also have to abide by the FTC’s guidelines. We ensure your website, packaging, point-of-sale, and other promotional materials comply with both agencies’ guidelines.
Off-label promotion: There are cases where your business can share medical and scientific information that discusses unapproved uses of the medical device. We offer regulatory counseling so you can develop policies and procedures around this type of content. We also help you train your marketing staff in the proceedings.
Adverse event reporting and record keeping: If you’ve received any complaints of malfunctions, acute injuries, or deaths related to your medical device, you’re obligated to report it to the FDA. With our services, you can develop standard operating procedures so you can quickly identify and publish these adverse events.
Warning Letter and border detention assistance: You may be panicking if you received a Warning Letter from the FDA or if your products are held up at the border. Don’t worry — we can help, but you have to act fast. There are cases where you’re able to fix the products, so you don’t have to destroy them. We help you respond and take action right away.
Have peace of mind knowing your medical device business is in good hands.
Know The subtle ways cosmetics differ from OTC drugs within FDA regulation
According to the FDA, cosmetics are defined by the way they are to be used: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Problems arise when cosmetics companies make drug or disease claims for their cosmetics products.
For example, if a cosmetic product claims that it will restore hair growth, reduce cellulite, or remove wrinkles, then these are considered to be drug-related claims. As a result, the product will then need to abide by the specific regulations relating to drugs. If you fail to understand these very subtle differences, you could face enforcement action by the FDA.
At FDACE PRO, we help your business navigate the tightrope between cosmetics and OTC drugs according to FDA regulations. Here’s what we do:
Ingredient and label review: We ensure any claims your product makes on the packaging or in your marketing materials comply with FDA rules and regulations for cosmetics.
OTC drug products: If you want to market your cosmetics product with drug claims, then you’ll need to meet the strict regulations of that industry. We guide you through the application process and ensure your business complies.
Get clarity on the language you can use on your cosmetics packaging and marketing. Click the button below to contact FDACE PRO to review the literature and more.
Get clarity on how to import products into the U.S properly.
Imported products are subject to detailed scrutiny by the FDA. If your products are unapproved, misbranded with improper labeling, or are potentially contaminated, you may face enforcement by the Agency.
Are your imported products held up by customs at the border? We can help you get back to business — but you have to act fast.
With over a decade of experience helping clients navigate time-sensitive FDA regulations, we know how to bring cases to quick resolutions. We can assist with:
Notice of Action: This notice advises that the FDA will hold the product for examination or sampling. It means that they have flagged a potential issue that could lead to the destruction or refusal of the shipment. We can help you quickly identify the reason for the detention, and find the right FDA contacts to resolve the issue. You only have seven days to respond to a Notice of Action, so you have to act now. A quick response will help you avoid other penalties like a warning letter.
Form 766: This is the process to resolve a Notice of Action, and it’s very time-sensitive. If your issue can be “reconditioned,” we prepare the FDA Form 766 Reconditioning Request and ensure it includes the correct details. This can help you avoid destroying your entire shipment.
Import Alert: If the FDA believes that your imported product “may appear” to violate regulations, they can use an Import Alert to identify product types, country of origin, and companies with prior violations, and detain the shipment for examination. The Import Alert is public and highly visible, leads to lengthy delays, and is best avoided when you’re trying to enter the market. We can help your business prevent an Import Alert by ensuring your paperwork is in order. If you are on the Import Alert already, we can petition to have your product removed.
Enter the market seamlessly by meeting FDA import regulations. Get in touch with us today so we can help you get back to business.
Manage your risk while increasing market share
FDA expertise for pre-market label reviews, permits, approvals, and more
Taking your business to the next level while remaining compliant is no easy feat.
Your products can make a significant difference in the lives of your customers, but getting them to market and ensuring they stand out against the competition is challenging when you have to keep FDA rules and regulations in mind.
Without detailed knowledge of FDA regulations, it’s hard to know what you can and cannot say on your labels and marketing materials, or when you need FDA approval. You need an experienced advocate who can help you navigate the guidelines while mitigating risk.
We take the worry out of getting your products to market.