ANDA Submission

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 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, and
  • Route of administration.

The Weinberg Group: ANDA Consulting Expertise

After we determine that your product meets these requirements, The Weinberg Group will review all relevant documentation and work with you to develop an ANDA filing plan which 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, and
  • Edit/write/translate as necessary to complete the module.

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