Drug Master File (DMF)
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Registrar Corp can assist you with the following:
- File a new DMF
- Update or Amend an existing DMF
- Appoint Registrar Corp as your Agent
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If you would like to file a new Drug Master File (DMF) with FDA
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If you already have a DMF number with FDA
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| Seçenek 1: Update your existing DMF
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Click the Update button below for any of the following:
- Amend your DMF
- File an Annual Update
- Reactivate a DMF
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Seçenek 2: Order a Certificate of Filing issued by Registrar Corp for your existing DMF
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Companies registered with FDA often are asked by their customers and suppliers to verify their DMF filing. A Certificate of Filing issued by Registrar Corp serves to verify your DMF.
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Section 314.420
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A master file for devices (MAF) is a way to preserve trade secrets of medical device companies and their suppliers. A medical device company often needs to submit information about their supplier's product, facility or process. The MAF allows each company to submit its own confidential data to FDA without it being disclosed to anyone outside FDA.
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| Registrar Corp FDA düzenlemeleri ile ilgili konularda danışmanlık hizmeti verir. Registrar Corp tarafından yayınlanan Kayıt sertifikanız sizin FDA kayıt gereklerine uygunluğunuzu doğrular. FDA kayıt sertifikası yayınlamaz veya kabul görmez. Registrar Corp, ABD Gıda ve İlaç İdaresine bağlı değildir.
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