Services to Ease FDA Regulatory Compliance

FAQ: GDUFA SELF INDENTIFICATION

How Can Pragmatic help you with Self Identification?

We just don’t submit your self identification, we also provide guidance on when to self identify, including whether GDUFA fees are applicable to your facility.  Our complete service includes assistance to get an FEI number and complete the self identification of your facility.

When Should I Self-Identify?

You should self identify if you are performing generic drug-related activities, including manufacturing, testing, or clinical studies.  It is more important to know when you should self identify. Our services can save you time and money.

How much time will it take to self-identify my facility?

With our support, the self-identification process takes about 48 hours.

How can I very my self-identification status?

The FDA publishes a list of all self-identified facility addresses, along with their type of business.

What information is required for self-identification?

Basic contact information is required, along with information about the nature of the operations – for example, FDF manufacturing or API manufacturing testing.

What about fees for self-identification?

Only facilities that manufacture, or intend to manufacture, generic drug APIs, FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or re-labelling are not required to pay a user fee.

Who needs to self-identify?

All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.

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