Prescription Drugs
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Registrar Corp can assist you with the following Prescription Drug requirements:
- FDA Establishment Registration
- Drug Listings and Label Submissions
- U.S. Agent Requirement
- Authorizing Official Requirement
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If you are not registered with FDA and have use of an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number
To register your establishment, list your Drugs, and obtain your Certificate of Registration issued by Registrar Corp:
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If you are already registered with FDA and use an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number
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Option 1: Update your exisitng Prescription Drug and Listing information
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Click the Update button below for any of the following:
- Update your Establishment Registration
- Update an existing Prescription Drug Listing
- List another Prescription drug
- Change U.S. Agent or Authorizing Official
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Option 2:
Order a Certificate of Registration issued by Registrar Corp
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Companies registered with FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with Prescription Drug Registration and Listing requirements.
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Part 207
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| Registrar Corp assists businesses with FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling FDA registration requirements. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the US Food and Drug Administration.
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