You Make the Product
We Make It Compliant
Your label reflects your brand. For the FDA, it’s a checklist one that includes active ingredient requirements, product claims, format requirements such as font sizes, mandatory warning language, and even the placement of information. Registrar Corp’s Label and Ingredient Review Services help you avoid misbranding risks by aligning your drug labels with FDA regulations from the outset.
3,000+ Drug Manufacturers Trust Registrar Corp
FDA Drug Regulation Isn’t Just Detailed - It’s Unforgiving
FDA drug regulations are strict and leave little room for error.
Both formulation and drug labels must comply with FDA pathways to be marketable in the US.
Active ingredients must align with an FDA drug monograph or face costly New Drug Application (NDA) requirements.
Drug labeling must follow 21 CFR Part 201 and specific monograph rules—detailing exact language, format, and placement.
Even small design tweaks can trigger regulatory issues.
Common labeling mistakes (e.g., missing warnings, improper Drug Facts layout, wrong font size) can lead to:
- Refused entry
- Warning letters
- Recalls
- Enforcement actions
Who We Help
Registrar Corp serves domestic and international drug companies seeking expert FDA compliance support. Whether you’re launching a new product or auditing your existing drug labels, our services are ideal for:
- Drug Manufacturers
- Contract Manufacturers
- Private Label Distributors
- Repackers and Relabelers
If you sell or export drugs in the United States, your formulation and labeling must comply with FDA rules. We help ensure your products comply with a monograph and the labels meet every legal requirement before the FDA takes a closer look.
What We Review
Verify that the active ingredients are generally recognized as safe and effective (GRASE) under an FDA drug monograph.
Compliance with OTC Drug Facts mandates: Ensures layout, headings,and format align with FDA Drug Facts labeling regulations.
Required warning and caution statements: Checks for inclusion of mandatory warnings based on the applicable monograph and FDA’s requirements in 21 CFR 201 and 330.
Approved indications and dosage instructions: Confirms claims and usage guidance follow regulatory requirements for that category of OTC drug.
Marketing claims and potential misbranding issues: Reviews language for non-compliance, or statements that exceed what FDA considers appropriate for that type of drug.
Graphic layout and font compliance: Our team of graphic designers will provide you with a print-ready revised label, incorporating all of our recommendations for compliance so that you can ship with confidence.
Why Clients Choose Us?
20+ years helping drug
companies meet FDA
labeling and formulation
requirements
Quick turnaround
and actionable
recommendations
In-house regulatory
specialists with deep
knowledge of 21 CFR 201 and
the FDA OTC Drug Review’s
monograph system
Integrated with our
product listing
and registration
services
Common Pitfalls We Help You Avoid
Shipping a product that has an inappropriate active ingredient
Omitting required warnings or other mandatory information
Using improper terms or unapproved claims
Misplaced information that violates FDA placement requirements
Incorrect formatting of Drug Facts panels
Contact Us
"*" indicates required fields