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Drugs

The United States regulates products intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of man or other animals. De system provides Registration, U.S. Agent, Authorizing Official and compliance assistance for India and Non-India companies in the Drug industry.

Over the Counter Drugs (OTC)

A human drug that is safe and effective for use without prescription by a licensed medical practitioner.

De system can assist you with the following OTC Drug requirements:
  • FDA Establishment Registration
  • Drug Listings and Label Submissions
  • U.S. Agent Requirement
  • Authorizing Official Designation
Label / Ingredient Reviews and Graphic Design Prescription Drugs

A human drug that is not safe for use except under the supervision of licensed medical practitioner.

De system can assist you with the following Prescription Drug requirements:
  • FDA Establishment Registration
  • Drug Listings and Label Submissions
  • U.S. Agent Requirement
Authorizing Official Designation Active Pharmaceutical Ingredients (API)

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.

De system can assist you with the following API requirements:
  • FDA Establishment Registration
  • Drug Listings and Label Submissions+
  • U.S. Agent Requirement
  • Authorizing Official Requirement
Drug Master File (DMF)

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.

De system can assist you with the following
  • File a new DMF
  • Update or Amend an existing DMF
  • Appoint us as your Agent.
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