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FDA Establishment Registration |
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Drug Listings and Label Submissions |
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U.S. Agent Requirement |
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Authorizing Official Designation |
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Label / Ingredient Reviews and Graphic Design |
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Prescription Drugs
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A human drug that is not safe for use except under the supervision of licensed medical practitioner. |
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De system can assist you with the following Prescription Drug requirements: |
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FDA Establishment Registration |
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Drug Listings and Label Submissions |
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U.S. Agent Requirement |
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Authorizing Official Designation |
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Active Pharmaceutical Ingredients (API)
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Any substance or mixture of substances (starting materials) intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product.
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De system can assist you with the following API requirements: |
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FDA Establishment Registration |
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Drug Listings and Label Submissions+ |
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U.S. Agent Requirement |
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Authorizing Official Requirement |
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Drug Master File (DMF) |
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A DMF is a submission to FDA that may be used in support of pre-market submissions to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human fda_drugs. |
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De system can assist you with the following: |
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File a new DMF |
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Update or Amend an existing DMF |
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Appoint us as your Agent. |
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