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U.S. FDA Drug Labeling Assistance

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Registrar Corp can assist you with U.S. FDA labeling requirements. Please complete the form below:

 I want to verify that my labeling meets current U.S. FDA requirements.
  I have a shipment detained due to labeling violations and need immediate assistance.
  I have not yet designed my product labeling and would like assistance.
Company Name: *
Contact Name: *
Contact Title: *
Facility Street Address: *
City: *
Country: *
Postal Code:
Phone: *
Mobile Phone:
E-mail: *
Type of Business (Select all that apply): *
Manufacturer - Owns or operates an establishment that manufactures a drug. This term includes, but is not limited to, control laboratories, contract laboratories, contract manufacturers, contract packers, contract labelers, and other entities that manufacture a drug.
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Repacker - Packages finished drugs from bulk or repackages drugs made by a manufacturer into different containers (excluding shipping containers).
Private Label Distributor - Any company engaged in distributing private label drugs (your company name appears on the label).
Other - Contract Testing Lab, Medical Gas Transfiller, Contract Assembler, Manufacturing Pharmacy, Fulfillment Packager, Contract Sterilizer, Labeler, Packer, PET Drug Production, Human Drug Outsourcing, Analysis, Particle Size Reduction, Recovery, and Regional Admixture Pharmacy.

* is required

U.S. FDA Regulations:

U.S. FDA Drug Labeling: 21 C.F.R. Part 201 Subparts A and C

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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