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Abbreviated New Drug Application (ANDA) Submissions

What is an ANDA?

Your generic drug development program has been relatively simple to this point. However, before filing your Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), you must be positive that your product is identical (bioequivalent) to the innovator drug product (the Reference Listed Drug). This means your product must match the innovator in:

  • Dosage form
  • Strength
  • Quality
  • Performance characteristics
  • Intended use
  • Route of administration

 

ProPharma Group: ANDA Consulting Expertise

After determining that your product meets these requirements, ProPharma Group will review all relevant documentation and work with you to develop an ANDA filing plan that balances risk, speed to approval, and cost. We will then produce your ANDA submission, completing all relevant modules. For each module, we will:

  • Determine the required content
  • Examine the content for suitability
  • Edit/write/translate as necessary to complete the module

We will compile and edit the completed ANDA, ensuring it is of sufficient excellence to meet the FDA’s rigorous standards and is thus ready for submission. When the document is finalized, we will convert it to the Electronic Common Technical Document (eCTD) format, so it is ready to be filed electronically with the FDA. If requested, ProPharma Group may also act as your Agent and submit the finished ANDA in eCTD format to the FDA.

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