Who’s Behind DrugLabelRight.com?
DrugLabelRight.com is a project of Maryland-based consulting firm FDAImports.com. Led by Founder and CEO, Benjamin England, FDAImports.com is a unique firm made up of consultants, marketers and affiliated attorneys serving FDA regulated international and domestic clients of all shapes and sizes. Mr. England is a 17-year veteran of the U.S. Food and Drug Administration with over 25 years of direct FDA-related experience, and who now leads FDAImports.com and ExportToUsa.com.cn, our Chinese subsidiary. DrugLabelRight.com is one of 5 sites developed specifically for helping companies with FDA labeling compliance.
How Does It Work?
You simply fill in your contact information and upload all your labels (including any retail cartons and immediate container labels) in any electronic image format. If you received an FDA warning letter, FDA detention notice or FDA notice of refusal of admission you can upload that as well. We will perform a fast initial review of all your documents and labels and respond back to you via email with the exact cost of your full label review and any other regulatory assistance you probably will need. Next you simply engage us to do the work, pay the cost and we perform the full-scale in-depth review. The whole label review process can be completed in as little as 3 days. Anything you upload will be kept confidential by our firm and we will not share your information with any third-parties. If there is an FDA enforcement involved with your matter, FDAImports.com can represent you to find a resolution.
Is it Free?
It’s free to upload your labels and receive your estimate. You’re not committed to pay anything for this initial step. We determine an exact cost for your label review based on the complexity of your product and packaging. You’re not committed to pay anything unless you want the label review. A typical review for a drug product costs between $1750 and $2250. Volume discounts may apply. In our email we’ll provide you with a payment link so that you can immediately submit your payment for faster processing. We accept all major credit cards, PayPal, wire transfer or check. We are based in Baltimore, MD and have been successfully helping companies all over the world with FDA compliance for years.
Is There a Discount for Multiple Labels?
Yes! We know that many companies produce a variety of products and we want to be your #1 resource for FDA compliance consulting. If you have more than 4 labels to review at a time we will create a special discount for you. Although we have the through-put for handling the needs of businesses of all sizes, we have a special affinity for helping midsize companies first entering the U.S. market. So please don’t hesitate to upload all of your documents at once so that we can work with you on a great discount. Just indicate in the “notes” area that you’re uploading 4 or more labels.
What Will I Get?
You will receive an electronic opinion letter containing a detailed assessment of every single portion of your label or package under the applicable laws and regulations. We will provide all of the following organized by panel and by area (Drug Facts, claims, etc…)
How Fast Is The Process?
The label review will begin upon successful receipt of your full flat-fee payment. The typical completion time is 10 business days after we receive the labels, documents and your payment, however, we can provide rush services for an additional premium.
What If I Need Custom Consulting or Research?
We are available for any of the following in addition to label reviews:
All of these services and more are available directly through our consulting firm, FDAImports.com. LEARN MORE
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