You will get FDA compliance review of one OTC, cosmetic, device, or supplement label

Jodi H.Status: Offline
Jodi H. Jodi H.
5.0
Top Rated

Let a pro handle the details

Buy Legal Consulting services from Jodi, priced and ready to go.
Jodi H.Status: Offline
Jodi H. Jodi H.
5.0
Top Rated

Let a pro handle the details

Buy Legal Consulting services from Jodi, priced and ready to go.

Project details

This is for FDA label compliance of your FDA regulated product, which can be an OTC (over-the-counter drug), cosmetic, medical device, supplement, or food. For quick/starter review, I can mark up your label where I recommend edits with short comments. For standard review, how I typically review labels, you will get a thorough review with a written report of recommended edits alongside label requirements, so you know the ins and outs for revisions and future labels. This report usually includes tips and other regulations outside of FDA compliance. The highest tier/advanced is for supplements that might have additional claims that need to be reviewed and substantiated and/or supplements or food that need the supplement/nutrition facts reviewed, as well. The review is for one front/back label and includes one re-review after edits are made. Additional reviews can be added on, and rush services can be provided, time permitting.
Field of Law
Health & Medical
Target Country
United States
Language
English
Service Type
Regulation & Compliance
What's included
Service Tiers Starter
$175
Standard
$250
Advanced
$350
Delivery Time 4 days 6 days 10 days
Number of Revisions
111
Optional add-ons You can add these on the next page.
Fast Delivery
+$70
Additional Revision
+$30
Inner/Outer Label review (+ 2 Days)
+$70

Frequently asked questions

5.0
148 reviews
97% Complete
3% Complete
1% Complete
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1% Complete
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1% Complete
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PH

Peter H.
5.00
Oct 6, 2023
Loved the report she gave me on my compliance issues in regards to product page! Very detailed and thorough! Would highly recommend her services for anyone looking for FDA guidance!
Peter

DB

Delilah B.
5.00
Aug 2, 2022
Very punctual and thorough work. I appreciated that the project included a revision. That was very helpful because I was able to make some proposed changes to the label and get some feedback.
Jodi H.Status: Offline

About Jodi

Jodi H.Status: Offline
FDA Quality & Regulatory - Label & Marketing Review - Registrations
100% Job Success
5.0  (148 reviews)
Dade City, United States - 3:40 am local time
I am a Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, cosmetic products and surface cleaners. Over the last 20 years I've held various senior and executive level management positions within FDA and EPA governed companies. I started my career as an Environmental Analytical Chemist and I held my most recent position for 9 years as QA/RA Director for a Henry Schein specialty company, Ortho Technology, a worldwide distributor of orthodontic medical devices. I would love to help you get your new product to the market, as I have experience in regulatory requirements in over 50 countries!

Some of my other specialties include technical writing to include SOPs (standard operating procedures), white papers, product submissions/dossiers, Organizational SOP writing (for any type of business), Overall Quality Management Systems that comply with ISO standards and various worldwide regulatory entities. I am well versed with FDA compliant advertising and can assist you with your device and drug label development and/or editing to ensure you are compliant to your jurisdiction. All of these skills require research, so yes, I am really good at that too!

My forte and favorite thing is label compliance review! I can review your device, OTC drug, supplement, food, and cosmetic labels for compliance to US FDA, EU Directives, Health Canada and more!

Check out my linked in profile for links to a few of the regulatory articles I have written recently. You can also search my name on the FDA website to find 510(k) evidence and other regulatory compliant reports that I have written and submitted.

Steps for completing your project

After purchasing the project, send requirements so Jodi can start the project.

Delivery time starts when Jodi receives requirements from you.

Jodi works on your project following the steps below.

Revisions may occur after the delivery date.

Review of Label Front/Back

I will review and send the project back to you in the format you choose: starter, standard, or advanced. Level of detail will depend on tier selected; advanced only needs selected for supplements with additional claims and/or supplement facts review.

Revision Review of "final label"

The is 2nd review after edits have been made based on compliance suggestions. I will review a second time to ensure the label is compliant and no new issues arose during edits. Note: This step awaits client edits in order to be completed.

Review the work, release payment, and leave feedback to Jodi.